Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 1...

FDA Device Recall #Z-1333-2023 — Class II — February 8, 2023

Recall Summary

Recall Number Z-1333-2023
Classification Class II — Moderate risk
Date Initiated February 8, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Sofamor Danek USA Inc
Location Memphis, TN
Product Type Devices
Quantity 10090 units

Product Description

Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; Demineralized Bone Matrix (DBM) product

Reason for Recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

Lot / Code Information

a) DBM S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC, REF S41150, GTIN 00613994961143, Serial Numbers: A43939, A47225 c) DBM T41110 0.5CC GRAFTON GEL, REF T41110, GTIN 00643169122956, Serial Numbers: A38528-100, A38528-101, A38528-102, A38528-103, A38528-104, A38528-105, A38528-106, A38910-058, A38910-059, A38910-060, A38910-061, A38910-062, A41224-053, A41224-054, A41224-055, A41224-056, A41224-057, A41224-058, A41224-059, A41224-060, A41224-061, A41224-062, A41224-063, A41224-064, A41224-065, A41224-066, A41224-067, A41224-068, A41224-069, A41224-070, A41224-071, A41224-072, A41935-025, A41935-026, A41935-027, A41935-028, A41935-029, A41935-030, A41935-031, A41935-032, A41935-033, A41935-034, A41935-035, A41935-036, A41935-037, A41935-038, A41935-039, A41935-040, A41935-041, A41935-042, A41935-043, A41935-044, A41935-045, A41935-046, A41935-047, A41935-048, A41935-049, A41935-050, A41935-051, A41935-052, A41935-053, A42221-076, A42221-077, A42221-078, A42221-079, A42221-080, A42221-081, A42221-082, A42221-083, A42221-084, A42221-085, A42619-011, A42619-012, A42619-013, A42619-014, A42619-015, A42619-016, A42619-017, A42619-018, A42619-019, A42619-020, A42619-021, A42619-022, A42619-023, A42619-024, A42619-025, A42619-026, A42619-027, A42619-028, A42619-029, A42619-030, A42619-031, A42619-032, A42619-033, A42619-034, A42619-035, A42619-036, A43231-127, A43231-128, A43286-011, A43286-012, A43286-013, A43286-014, A43286-015, A43286-016, A43286-017, A43286-018, A43286-019, A43286-020, A43286-021, A43286-022, A43286-023, A43286-024, A43286-025, A43286-026, A43286-027, A43286-028, A43286-029, A43286-030, A43286-031, A43286-032, A43286-033, A43286-034, A43286-035, A43286-036, A43286-037, A43286-038, A43286-039, A43286-040, A43286-041, A43286-042, A43286-043, A43286-044, A43286-045, A43286-046, A43286-047, A43286-048, A43286-049, A43286-050, A43286-051, A43286-052, A43286-053, A43286-054, A43286-055, A43286-056, A43286-057, A43286-058, A43286-059, A43286-060, A43286-061, A46158-011, A46158-012, A46158-013, A46158-014, A46158-015, A46158-016, A46158-017, A46158-018, A46158-019, A46158-020, A46158-021, A46158-022, A46158-023, A46158-024, A46158-025, A46158-026, A46158-027, A46158-028, A46158-029, A46158-030, A46158-031, A46158-032, A46158-033, A46158-034, A46158-035, A46158-036, A46158-037, A46158-038, A46158-039, A46158-040, A46158-041, A46158-042, A46158-043, A46158-044, A46158-045, A46158-046, A46158-047, A46158-048, A46158-049, A46158-050, A46158-051, A46158-052, A46158-053, A46158-054, A46158-055, A46158-056, A47115-011, A47115-012, A47115-013, A47115-014, A47115-015, A47115-016, A47115-017, A47115-018, A47115-019, A47115-020, A47115-021, A47115-022, A47115-023, A47115-024, A47115-025, A47115-026, A47115-027, A47115-028, A47115-029, A47115-030, A47115-031, A47115-032, A47115-033, A47115-034, A47115-035, A47115-036, A47115-037, A47115-038, A47115-039, A47115-040, A47293-011, A47293-012, A47293-013, A47293-014, A47293-015, A47293-016, A47293-017, A47293-018, A47293-019, A47293-020, A47293-021, A47293-022, A47293-023, A47293-024, A47293-025, A47293-026, A47293-027, A47293-028, A47293-029, A47293-030, A47293-031, A47293-032, A47293-033, A47293-034, A47293-035, A47293-036, A47431-041, A47431-042, A47431-043, A47431-044, A47431-045, A47431-046, A47431-047, A47431-048, A47431-049, A47431-050, A47431-051, A47431-052, A47431-053, A47431-054, A47431-055, A47431-056, A47431-057, A47431-058, A47431-059, A47431-060, A47431-061, A47431-062, A47431-063, A47431-064, A47431-065, A47431-066, A47431-067, A47431-068, A47431-069, A47431-070, A47431-071, A47431-072, A47431-073, A47431-074, A47431-075, A47431-076, A47431-077, A47431-078, A47431-079, A47431-080, A47431-081, A47431-082, A47573-030, A47573-031, A47573-032, A47573-033, A47573-034, A47573-035, A47573-036, A47573-037, A47573-038, A47573-039, A47573-040, A47573-041, A47573-042, A47573-043, A47573-044, A47573-045, A47573-046, A47573-047, A47573-048, A47573-049, A47573-050, A47573-051, A47573-052, A47573-053, A47573-054, A47573-055, A47573-056, A47573-057, A47573-058, A47573-059, A47573-060, A47573-061, A47573-062, A47573-063, A47573-064, A47573-065, A47573-066, A47573-067, A47573-068, A47573-069, A47573-070, A47573-071, A47573-072, A47573-073, A47573-074, A47573-075, A47573-076, A47573-077, A47573-078, A47573-079, A47573-080, A47573-081, A47573-082, A47573-083, A47573-084, A47573-085, A47573-086, A47573-087, A47573-088, A47573-089, A47573-090, A47573-091, A47573-092, A47573-093, A47573-094, A47573-095, A47672-060, A47672-061, A47672-062, A47672-063, A47672-064, A47672-065, A47672-066, A47672-067, A47672-068, A47672-069, A47672-070, A47672-071, A47672-072, A47672-073, A47672-074, A47672-075, A47672-076, A47672-077, A47672-078, A47672-079, A47672-080, A47672-081, A47672-082, A47672-083, A47672-084, A47672-085, A47672-086, A47672-087, A47672-088, A47672-089, A47672-090, A47672-091, A47672-092, A47672-093, A47672-094, A48441-046, A48441-047, A48441-048, A48441-049, A48441-050, A48441-051, A48441-052, A48441-053, A48441-054, A48441-055, A48441-056, A48441-057, A48441-058, A48441-059, A48441-060, A48441-061, A48441-062, A48441-063, A48441-064, A48441-065, A48441-066, A48441-067, A48441-068, A48441-069, A48441-070, A48441-071, A48441-072, A48441-073, A48441-074, A48441-075, A48441-076, A48441-077, A48441-078, A48441-079, A48441-080, A48441-081, A48441-082, A48441-083, A48441-084, A48441-085, A48441-086, A48441-087, A48441-088, A48441-089, A48441-090, A48441-091, A48538-115, A48538-116, A48538-117, A48538-118, A48538-119, A48538-120, A48538-121, A48538-122, A48538-123, A48538-124, A48538-125, A48538-126, A48538-127, A48538-128, A48538-129, A48538-130, A48538-131, A48538-132, A48538-133, A48538-134, A48538-135, A48538-136, A48538-137, A48538-138, A48538-139, A48538-140, A48538-141, A48538-142, A48538-143, A48538-144, A48538-145, A48538-146, A48538-147, A48538-148, A48538-149, A48538-150, A49912-056, A49912-057, A49912-058, A49912-059, A49912-060, A49912-061, A49912-062, A49912-063, A49912-064, A49912-065, A49912-066, A49912-067, A49912-068, A49912-069, A49912-070, A49912-071, A49912-072, A49912-073, A49912-074, A49912-075, A49912-076, A49912-077, A49912-078, A49912-079, A49912-080, A49912-081, A49912-082, A49912-083, A49912-084, A49912-085, A49912-086, A49912-087, A49912-088, A49912-089, A49912-090, A49912-091, A49912-092, A49912-093, A49975-051, A49975-052, A49975-053, A49975-054, A49975-055, A49975-056, A49975-057, A49975-058, A49975-059, A49975-060, A49975-061, A49975-062, A49975-063, A49975-064, A49975-065, A49975-066, A49975-067, A49975-068, A49975-069, A49975-070, A49975-071, A49975-072, A49975-073, A49975-074, A49975-075, A49975-076, A49975-077, A49975-078, A49975-079, A52779-011, A52779-012, A52779-013, A52779-014, A52779-015, A52779-016, A52779-017, A52779-018, A52779-019, A52779-020, A52779-021, A52779-022, A52779-023, A53118-021, A53118-022, A53118-023, A53118-024, A53118-025, A53118-026, A53118-027, A53118-028, A53118-029, A53118-030, A53118-031, A53118-032, A53118-033, A53118-034, A53118-035, A53118-036, A53118-037, A53118-038, A53118-039, A53118-040, A53118-041, A53118-042, A53118-043, A53118-044, A53118-045, A53118-046, A53118-047, A53118-048, A53118-049, A53118-050, A53118-051, A53118-052, A53118-053, A53118-054, A53118-055, A53118-056, A53118-057, A53118-058, A53118-059, A53118-060, A53118-061, A53118-062, A53118-063, A53118-064, A53118-065, A53118-066, A53118-067, A53118-068, A53118-069, A53118-070, A53118-071, A53118-072, A53118-073, A53118-074, A53118-075, A53118-076, A53118-077, A53118-078, A53118-079, A53118-080, A53118-081, A53177-011, A53177-012, A53177-013, A53177-014, A53177-015, A53177-016, A53177-017, A53177-018, A53177-019, A53177-020, A53177-021, A53177-022, A53177-023, A53177-024, A53177-025, A53177-026, A54244-064, A54244-065, A54244-066, A54244-067, A54244-068, A54244-069, A54244-070, A54244-071, A54244-072, A54244-073, A54350-034, A54350-035, A54350-036, A54350-037, A54350-038, A54350-039, A54350-040, A54350-041, A54350-042, A54350-043, A54350-044, A54350-045, A54350-067, A54350-068, A54350-069, A54350-070; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT, GTIN 00643169964839, Serial Numbers: A37724-094, A37724-095, A37724-096, A37724-097, A37724-098, A37724-099, A37724-100, A37724-101, A37724-102, A37724-103, A37724-104, A37724-105, A37724-106, A37724-107, A37724-108, A37724-109, A37724-110, A37724-111, A37724-112, A37724-113, A37724-114, A37724-115, A37724-116, A37724-117, A37724-118, A37724-119, A37724-120, A37724-121, A37724-122, A37724-123, A37724-124, A37724-125, A37724-126, A39537-031, A39537-032, A39537-033, A39537-034, A39537-035, A39537-036, A39537-037, A39537-038, A39537-039, A39537-040, A39537-041, A39537-042, A39537-043, A39537-044, A39537-045, A39537-046, A39537-047, A39537-048, A39537-049, A39537-050, A39537-051, A39537-052, A39537-053, A42444-041, A42444-042, A42444-043, A42444-044, A42444-045, A42444-046, A42444-047, A42444-048, A42444-049, A42444-050, A42444-051, A42444-052, A42571-102, A42571-103, A42571-104, A42571-105, A42571-106, A42571-107, A42571-108, A42571-109, A42780-068, A42780-069, A42780-070, A42780-071, A42780-072, A42780-073, A42780-074, A42780-075, A42780-076, A42780-077, A42780-078, A42780-079, A42780-080, A42780-081, A42780-082, A42780-083, A42780-084, A42780-085, A42780-086, A42780-087, A42780-088, A42780-089, A42780-090, A42780-091, A42780-092, A42780-093, A42780-094, A42780-095, A42780-096, A42780-097, A42780-098, A42780-099, A42780-100, A42780-101, A43098-042, A43098-043, A43098-044, A43098-045, A43098-046, A43098-047, A43098-048, A43098-049, A43098-050, A43098-051, A43098-052, A43098-053, A43098-054, A43098-055, A43098-056, A43098-057, A43098-058, A43098-059, A43098-060, A43098-061, A43098-062, A43098-063, A43098-064, A43284-036, A43284-037, A43284-038, A43284-039, A43284-040, A43284-041, A43284-042, A43284-043, A43284-044, A43284-045, A43286-067, A43286-068, A43286-069, A43286-070, A43286-071, A43286-072, A43286-073, A43286-074, A43286-075, A43286-076, A43286-077, A43286-078, A43286-079, A43286-080, A43286-081, A43286-082, A43858-011, A43858-012, A43858-013, A43858-014, A43858-015, A43858-016, A43858-017, A43858-018, A43858-019, A43858-020, A43858-021, A43858-022, A43858-023, A43858-024, A43858-025, A43858-026, A43858-027, A43858-028, A43858-029, A43858-030, A43858-031, A43858-032, A43858-033, A43858-034, A43858-035, A43858-036, A43858-037, A43858-038, A43858-039, A43858-040, A43858-041, A43858-042, A43858-043, A43858-044, A43858-045, A43858-046, A43858-047, A43858-048, A43858-049, A43858-050, A43858-051, A43858-052, A43858-053, A43858-054, A43858-055, A43858-056, A43858-057, A43858-058, A43858-059, A43858-060, A43858-061, A44260-011, A44260-012, A44260-013, A44260-014, A44260-015, A44260-016, A44260-017, A44260-018, A44260-019, A44260-020, A44260-021, A44260-022, A44260-023, A44260-024, A44260-025, A46158-057, A46158-058, A46158-059, A46158-060, A46158-061, A46158-062, A46158-063, A46158-064, A46158-065, A46158-066, A46333-031, A46333-032, A46333-033, A46333-034, A46333-035, A46333-036, A46333-037, A46333-038, A46333-039, A46333-040, A46333-041, A46333-042, A46333-043, A46333-044, A46333-045, A46333-046, A46333-047, A46333-048, A46333-049, A46333-050, A46333-051, A46333-052, A46333-053, A46791-011, A46791-012, A46791-013, A46791-014, A46791-015, A46791-016, A46791-017, A46791-018, A46791-019, A46791-020, A46791-021, A46791-022, A46791-023, A46791-024, A46791-025, A46791-026, A46791-027, A47034-041, A47034-042, A47034-043, A47034-044, A47034-045, A47034-046, A47034-047, A47034-048, A47034-049, A47034-050, A47034-051, A47034-052, A47034-053, A47034-054, A47034-055, A47034-056, A47034-057, A47034-058, A47034-059, A47034-060, A47034-061, A47034-062, A48114-084, A48114-085, A48114-086, A48114-087, A48114-088, A48114-089, A48114-090, A48114-091, A48114-092, A48114-093, A48114-094, A48114-095, A48114-096, A48114-097, A48114-098, A48114-099, A48114-100, A48114-101, A48699-011, A48699-012, A48699-013, A48699-014, A48699-015, A48699-016, A48699-017, A48699-018, A48699-019, A48699-020, A48699-021, A48699-022, A48699-023, A48699-024, A48699-025, A48699-026, A48699-027, A48699-028, A48699-029, A48699-030, A48699-031, A48699-032, A49529-011, A49529-012, A49529-013, A49529-014, A49529-015, A49529-016, A49529-017, A49529-018, A49529-019, A49529-020, A49529-021, A49529-022, A49529-023, A49529-024, A49529-025, A49529-026, A49529-027, A49529-028, A49529-029, A51547-041, A51547-042, A51547-043, A51547-044, A51547-045, A51547-046, A51547-047, A51547-048, A53185-011, A53185-012, A53185-013, A53185-014, A53185-015; e) DBM T41120 1CC GRAFTON GEL, REF T41120, GTIN 00643169122963, Serial Numbers: A38528-107, A38528-108, A38528-109, A38528-110, A38528-111, A38528-112, A38528-113, A38528-114, A38528-115, A38528-116, A38528-117, A38528-118, A38528-119, A38528-120, A38528-121, A38528-122, A38528-123, A38528-124, A38528-125, A38528-126, A38528-127, A38528-128, A38528-129, A38528-130, A38528-132, A38528-133, A38528-134, A38528-135, A38528-136, A38528-137, A38528-138, A38528-139, A38528-140, A38528-141, A38528-142, A38528-143, A38528-144, A38528-145, A38528-146, A38528-147, A38528-148, A38528-149, A38528-150, A38528-151, A38528-152, A38528-153, A38528-154, A38528-155, A38528-156, A38528-157, A38528-158, A38528-159, A38528-160, A38528-161, A38528-162, A38528-163, A38528-165, A38528-166, A38528-167, A38528-168, A38528-169, A38528-170, A38528-171, A38528-172, A38528-173, A38528-174, A38528-175, A38528-176, A38528-177, A38528-178, A38528-179, A38528-180, A38528-181, A38528-182, A38528-183, A38528-184, A38528-185, A38528-186, A38528-187, A38528-188, A38528-189, A38528-190, A38528-191, A38528-192, A38528-194, A38528-195, A38528-196, A38528-197, A38528-198, A38528-199, A38528-200, A38528-201, A38528-202, A38528-203, A38528-204, A38528-205, A38528-206, A38528-207, A39248-129, A39248-130, A39248-131, A39248-132, A39248-133, A39248-134, A39248-135, A39248-136, A39248-137, A39248-138, A39248-139, A39248-140, A39248-141, A39248-142, A39248-143, A39248-144, A39248-145, A39248-146, A39248-147, A39248-148, A39248-149, A39248-150, A39248-152, A39248-153, A39248-154, A39248-155, A39248-157, A39248-158, A39248-159, A39248-160, A39248-161, A39248-162, A39248-163, A39248-164, A39248-165, A39248-166, A39248-167, A39248-168, A39248-169, A39248-170, A39248-171, A39248-172, A39248-173, A39248-174, A39248-175, A39248-176, A39248-177, A39248-178, A39248-179, A39248-180, A39248-181, A39248-182, A39248-183, A39248-184, A39248-185, A39248-186, A39248-187, A39248-188, A39248-189, A39248-190, A39248-191, A39248-192, A39248-193, A39248-194, A39248-195, A39248-196, A39248-197, A39248-198, A39248-199, A39248-200, A39248-201, A39248-202, A39248-203, A39248-204, A39248-205, A39248-206, A39248-207, A39248-208, A39248-209, A39248-210, A39248-211, A39248-212, A39248-213, A39248-214, A39248-215, A39248-216, A39248-217, A39248-219, A39248-220, A39248-221, A39248-222, A39248-223, A39248-224, A39248-225, A39248-226, A39248-227, A39248-228, A39248-229, A39248-230, A39248-231, A39248-232, A39248-233, A39248-234, A39248-235, A39248-236, A40738-117, A40738-118, A40738-119, A40738-120, A40738-121, A40738-122, A40738-123, A40738-124, A40738-125, A40738-126, A40738-127, A40738-128, A40738-129, A40738-130, A40738-131, A40738-132, A40738-133, A40738-134, A40738-135, A40738-136, A40738-137, A40738-138, A40738-139, A40738-140, A40738-141, A40738-142, A40738-143, A40738-144, A40738-145, A40738-146, A40738-147, A40738-148, A40738-149, A40738-150, A40738-151, A40738-152, A40738-153, A40738-154, A42221-086, A42221-087, A42221-088, A42221-089, A42221-090, A42221-091, A42221-092, A42221-093, A42221-094, A42221-095, A42221-096, A42221-097, A42221-098, A42221-099, A42221-100, A42221-101, A42221-102, A42221-103, A42221-104, A42221-105, A42221-106, A42221-107, A42221-108, A42221-109, A42221-110, A42221-111, A42221-112, A42221-113, A42221-114, A42221-115, A42221-116, A42221-117, A42221-118, A42221-119, A42221-120, A42221-121, A42221-122, A42221-123, A42221-124, A42221-125, A42221-126, A42221-127, A42221-128, A42221-129, A42221-130, A42221-131, A42221-132, A42221-133, A42221-134, A42221-135, A42221-136, A42221-137, A42221-138, A42221-139, A42221-140, A42221-141, A42221-142, A42221-143, A42221-144, A42221-145, A42221-146, A42221-147, A42221-148, A42221-149, A42221-150, A42221-151, A42221-152, A42221-153, A42221-154, A42221-155, A42221-156, A42221-157, A42221-158, A42221-159, A42221-160, A42221-161, A42221-162, A42221-163, A42221-164, A42221-165, A42221-166, A42221-167, A42221-168, A42221-169, A42221-170, A42221-171, A42221-172, A42221-173, A42221-174, A42221-175, A42221-176, A42221-177, A42221-178, A42221-179, A42221-180, A42221-181, A42221-182, A42221-183, A42221-184, A42221-185, A42221-186, A42221-187, A42221-188, A42221-189, A42221-190, A42221-191, A42221-192, A42545-014, A42545-015, A42545-016, A42545-017, A42545-018, A42545-019, A42545-020, A42545-021, A42545-022, A42545-023, A42545-024, A42545-026, A42545-027, A42545-028, A42545-029, A42545-030, A42545-031, A42545-032, A42545-033, A42545-034, A42545-035, A42545-036, A42545-037, A42545-038, A42545-039, A42545-040, A42545-041, A42545-042, A42545-043, A42545-044, A42545-045, A42545-046, A42545-047, A42545-048, A42545-049, A42545-050, A42545-051, A42545-052, A42545-053, A42545-054, A42545-055, A42545-056, A42545-057, A42545-058, A42545-059, A42545-060, A42545-061, A42545-062, A42545-063, A42545-064, A42545-065, A42545-066, A42545-067, A42545-068, A42545-069, A42545-070, A42545-071, A42545-072, A42545-073, A42545-074, A42545-075, A42545-076, A42545-077, A42545-078, A42545-079, A42545-080, A42545-081, A42545-082, A42545-083, A42545-084, A42545-085, A42545-086, A42545-087, A42545-088, A42545-089, A42545-090, A42545-091, A42545-092, A42545-093, A42545-094, A42545-095, A42982-039, A42982-040, A42982-041, A42982-042, A42982-043, A42982-044, A42982-045, A42982-046, A42982-047, A42982-048, A42982-049, A42982-050, A42982-051, A42982-052, A42982-053, A42982-054, A42982-055, A42982-056, A42982-057, A42982-058, A42982-059, A42982-060, A42982-061, A42982-062, A42982-063, A42982-064, A42982-065, A42982-067, A42982-068, A42982-069, A42982-070, A42982-071, A42982-072, A42982-073, A42982-074, A42982-075, A42982-076, A42982-077, A42982-078, A42982-079, A42982-080, A42982-081, A42982-082, A42982-083, A42982-084, A42982-085, A42982-086, A42982-087, A42982-088, A42982-089, A42982-090, A42982-091, A42982-092, A42982-093, A42982-094, A43231-011, A43231-012, A43231-013, A43231-015, A43231-016, A43231-017, A43231-018, A43231-019, A43231-020, A43231-021, A43231-022, A43231-023, A43231-024, A43231-025, A43231-026, A43231-027, A43231-028, A43231-029, A43231-030, A43231-031, A43231-032, A43231-033, A43231-034, A43231-035, A43231-036, A43231-037, A43231-038, A43231-039, A43231-040, A43231-041, A43231-042, A43231-043, A43231-044, A43231-045, A43231-046, A43231-047, A43231-048, A43231-049, A43231-050, A43231-051, A43231-052, A43231-053, A43231-054, A43231-055, A43231-056, A43231-057, A43231-058, A43231-059, A43231-060, A43231-061, A43231-062, A43231-063, A43231-064, A43231-065, A43231-066, A43231-067, A43231-068, A43231-069, A43231-070, A43231-071, A43231-072, A43231-073, A43231-074, A43231-075, A43231-076, A43231-077, A43231-078, A43231-079, A43231-080, A43231-081, A43231-082, A43231-083, A43231-084, A43231-085, A43231-086, A43231-087, A43231-088, A43231-089, A43231-090, A43231-091, A43231-092, A43231-093, A43231-094, A43231-095, A43231-096, A43231-097, A43231-098, A43231-099, A43231-100, A43231-101, A43231-102, A43231-103, A43231-104, A43231-105, A43231-106, A43231-107, A43231-108, A43231-109, A43231-110, A43231-111, A43231-112, A43231-113, A43231-114, A43231-115, A43231-116, A43231-117, A43231-118, A43231-119, A43231-120, A43231-121, A43231-122, A43231-123, A43231-124, A43231-125, A43231-126, A43336-040, A43336-041, A43336-042, A43336-043, A43336-044, A43336-045, A43336-046, A43336-047, A43336-048, A43336-049, A43336-050, A43336-051, A43336-052, A43336-053, A43336-054, A43336-055, A43336-056, A43336-057, A43336-058, A43336-059, A43336-060, A43336-061, A43336-062, A43336-063, A43336-064, A43336-065, A43336-066, A43336-067, A43336-068, A43336-069, A43336-070, A43336-071, A43336-072, A43336-073, A43336-074, A43336-075, A43336-076, A43336-077, A43336-078, A43336-079, A43336-080, A43336-081, A43336-082, A43336-083, A43336-084, A43336-085, A43336-086, A43336-087, A43336-088, A43336-089, A43336-090, A43336-091, A43336-092, A43336-093, A43336-094, A43336-095, A43336-096, A43336-097, A43336-098, A43336-099, A43336-100, A43336-101, A43336-102, A43336-103, A43336-104, A43336-105, A43336-106, A43336-107, A43336-108, A43336-109, A43336-110, A43336-111, A43336-112, A43336-113, A43336-114, A43336-115, A43336-116, A43336-117, A43344-248, A43344-249, A43344-250, A43344-251, A43344-252, A43344-253, A43344-254, A43344-255, A43344-256, A43344-257, A43344-258, A43344-259, A43344-260, A43344-261, A43344-262, A43344-263, A43344-264, A43344-265, A43344-266, A43344-267, A43344-268, A43344-269, A43344-270, A43344-271, A43344-272, A43344-273, A43344-274, A43344-275, A43344-276, A43344-277, A43344-278, A43344-279, A43344-280, A43344-281, A43344-282, A43344-283, A43344-284, A43344-285, A43344-286, A43344-287, A43344-288, A43344-289, A43344-290, A43344-291, A43344-292, A43344-293, A43344-294, A43344-295, A43344-296, A43344-297, A43344-298, A43344-299, A43344-300, A43344-301, A43344-302, A43344-303, A43344-304, A43344-305, A43344-306, A43344-308, A43344-309, A43344-310, A43344-311, A43344-312, A43344-313, A43344-314, A43344-315, A43344-316, A43344-317, A43345-096, A43345-097, A43345-098, A43345-099, A43345-100, A43345-101, A43345-102, A43345-103, A43345-104, A43345-105, A43345-106, A43345-107, A43345-108, A43345-109, A43345-110, A43345-111, A43345-112, A43345-113, A43345-114, A43345-115, A43345-116, A43345-117, A43345-118, A43345-119, A43345-120, A43345-121, A43345-122, A43345-123, A43345-124, A43345-125, A43345-126, A43345-127, A43345-128, A43345-129, A43345-130, A43345-131, A43345-132, A43345-133, A43345-134, A43345-135, A43345-136, A43345-137, A43345-138, A43345-139, A43345-140, A43345-141, A43345-142, A43345-143, A43345-144, A43345-145, A43345-146, A43345-147, A43345-148, A43345-149, A43345-150, A43345-151, A43345-152, A43345-153, A43345-154, A43345-155, A44405-011, A44405-012, A44405-013, A44405-014, A44405-015, A44405-016, A44405-017, A44405-018, A44405-019, A44405-020, A44405-021, A44405-022, A44405-023, A44405-024, A44405-025, A44405-026, A44405-027, A44405-028, A44405-029, A44405-030, A44405-031, A44405-032, A44405-033, A44405-034, A44405-035, A44405-036, A44405-037, A44405-038, A44405-039, A44405-040, A44405-041, A44405-042, A44405-043, A44405-044, A44405-045, A44405-046, A44405-047, A44405-048, A44405-049, A44405-050, A44405-051, A44405-052, A44405-053, A44405-054, A44413-051, A44413-052, A44413-053, A44413-054, A44413-055, A44413-056, A44413-059, A44413-060, A44413-061, A44413-062, A44413-063, A44413-064, A44413-065, A44413-066, A44413-067, A44413-068, A44413-069, A44413-070, A44413-071, A44413-072, A44413-073, A44413-074, A44413-075, A44413-076, A44413-077, A44413-078, A44413-079, A44413-080, A44413-081, A44413-082, A44413-083, A44413-084, A44413-085, A44413-086, A44413-087, A44413-088, A44413-089, A44413-090, A44413-091, A44413-092, A44413-093, A44413-094, A44413-095, A44413-097, A44413-098, A44413-099, A44413-100, A44413-101, A44413-102, A44413-103, A44413-104, A44413-105, A44413-106, A44413-108, A44413-109, A44413-110, A44413-111, A44413-112, A44413-113, A44413-114, A44413-115, A44413-116, A44413-117, A44413-118, A44413-119, A44413-120, A44413-121, A44413-122, A44413-123, A44413-124, A44413-125, A44413-126, A44413-127, A44413-128, A44413-129, A44413-130, A44413-131, A44413-132, A44413-133, A44413-134, A44413-135, A44413-136, A44413-137, A44413-138, A44413-139, A44413-140, A44413-141, A44413-142, A44413-143, A44413-144, A44413-145, A44413-146, A44413-147, A44413-148, A44413-149, A44413-150, A44413-151, A44413-152, A44413-153, A44413-154, A44413-155, A44413-156, A44413-157, A44413-158, A44413-159, A44413-160, A44413-161, A44413-162, A44413-163, A44413-164, A44413-165, A44413-166, A44413-167, A44413-168, A44413-169, A44413-170, A44413-171, A44413-172, A44413-173, A44413-174, A44413-175, A44413-176, A44413-177, A44413-178, A44413-179, A44413-180, A44413-181, A44413-182, A44413-183, A44413-184, A44413-185, A44413-186, A44413-187, A44413-188, A45217-080, A45217-081, A45217-082, A45217-083, A45217-084, A45217-085, A45217-086, A45217-087, A45217-088, A45217-089, A45217-090, A45217-091, A45217-092, A45217-093, A45217-094, A45217-095, A45217-096, A45217-097, A45217-098, A45217-099, A45217-100, A45217-101, A45217-102, A45217-103, A45217-104, A45217-105, A45217-106, A45217-107, A45217-108, A45217-109, A45217-110, A45217-111, A45217-112, A45217-113, A45217-114, A45217-115, A45217-116, A45217-117, A45217-118, A45217-119, A45217-120, A45217-121, A45217-122, A45217-123, A45217-124, A45217-125, A45217-126, A45217-127, A45217-129, A45217-130, A45217-131, A45217-132, A45217-133, A45217-135, A45217-136, A45217-137, A45217-138, A45217-139, A45217-140, A45217-141, A45217-142, A45217-143, A45217-144, A45217-145, A45217-146, A45217-147, A45217-148, A45217-149, A45217-150, A45217-151, A45217-152, A45217-153, A45217-154, A45217-155, A45217-156, A45217-157, A45217-158, A45217-159, A45217-160, A45217-161, A45217-162, A45217-163, A45217-164, A45217-165, A45217-166, A45217-167, A45217-168, A45613-046, A45613-047, A45613-048, A45613-049, A45613-050, A45613-051, A45613-052, A45613-053, A45613-054, A45613-055, A45613-056, A45613-057, A45613-058, A45613-059, A45613-060, A45613-061, A45613-062, A45613-063, A45613-064, A45613-065, A45613-066, A45613-067, A45613-068, A45613-069, A45613-070, A45613-071, A45613-072, A45613-073, A45613-074, A45613-075, A45613-076, A45613-077, A45613-078, A45613-079, A45613-080, A45613-081, A45613-082, A45613-083, A45613-084, A45613-085, A45613-086, A45613-087, A45613-088, A45613-089, A45613-090, A45613-091, A45613-092, A45613-093, A45613-094, A45613-095, A45613-096, A45613-097, A45613-098, A45613-099, A45613-100, A45613-101, A45613-102, A45613-103, A45613-104, A45613-105, A45613-106, A45613-107, A45613-108, A45613-109, A45613-110, A45613-111, A45613-112, A45613-113, A45613-114, A45613-115, A45613-116, A45613-117, A45613-118, A45613-119, A45613-120, A45613-121, A45613-122, A45613-123, A45613-124, A45613-125, A45613-126, A45613-127, A45613-128, A45613-129, A45613-130, A45613-131, A45613-132, A45613-133, A45613-134, A45613-135, A45613-136, A45613-137, A46849-026, A46849-027, A46849-028, A46849-029, A46849-030, A46849-031, A46849-032, A46849-033, A46849-034, A46849-035, A46849-036, A46849-037, A46849-038, A46849-039, A46849-040, A46849-041, A46849-042, A46849-043, A46849-044, A46849-045, A46849-046, A46849-047, A46849-048, A46849-049, A46849-050, A46849-051, A46849-052, A46849-053, A46849-054, A46849-055, A46849-056, A46849-057, A46849-058, A46849-059, A46849-060, A46849-061, A46849-062, A46849-063, A46849-064, A46849-065, A46849-066, A46849-067, A46849-068, A46849-069, A46849-070, A46849-071, A46849-072, A46849-073, A46849-074, A46849-075, A46849-076, A46849-077, A46849-078, A46849-079, A46849-080, A46849-081, A46849-082, A46849-083, A46849-084, A46849-085, A46849-086, A46849-087, A46849-088, A46849-089, A46849-090, A46849-091, A46849-092, A46849-093, A46849-094, A46849-095, A47127-103, A47127-104, A47127-105, A47127-106, A47127-107, A47127-108, A47127-109, A47127-110, A47127-112, A47127-113, A47127-114, A47127-115, A47127-116, A47127-117, A47127-118, A47127-119, A47127-120, A47127-121, A47127-122, A47127-123, A47127-124, A47127-125, A47127-126, A47127-127, A47127-128, A47127-129, A47127-130, A47127-131, A47127-132, A47127-133, A47127-134, A47127-135, A47127-136, A47127-137, A47127-138, A47127-139, A47127-140, A47127-141, A47127-142, A47127-143, A47127-144, A47127-145, A47127-146, A47127-147, A47127-148, A47127-149, A47127-150, A47127-151, A47127-152, A47127-153, A47127-154, A47127-155, A47127-156, A47127-157, A47127-158, A47127-159, A47127-160, A47127-161, A47127-162, A47127-163, A47127-164, A47127-165, A47127-166, A47127-167, A47127-168, A47127-169, A47127-170, A47127-171, A47127-172, A47127-173, A47127-174, A47127-175, A47127-176, A47127-177, A47127-178, A47127-179, A47127-180, A47127-181, A47127-182, A47127-183, A47127-184, A47127-185, A47127-186, A47127-187, A47127-188, A47127-189, A47127-190, A47127-191, A47127-192, A47127-193, A47127-194, A47127-195, A47127-196, A47127-197, A47127-198, A47127-199, A47127-200, A47127-201, A47127-202, A47127-203, A47127-204, A47127-205, A47127-206, A47127-207, A47127-208, A47127-209, A47293-037, A47293-038, A47293-039, A47293-040, A47293-041, A47293-042, A47293-043, A47293-044, A47293-045, A47293-046, A47293-047, A47293-048, A47293-049, A47293-050, A47293-051, A47293-052, A47293-053, A47293-054, A47293-055, A47293-056, A47293-057, A47293-058, A47293-059, A47293-060, A47293-061, A47293-062, A47293-063, A47293-064, A47293-065, A47293-066, A47293-067, A47293-068, A47293-071, A47293-072, A47293-073, A47293-074, A47293-075, A47293-076, A47293-077, A47293-078, A47293-079, A47293-080, A47293-081, A47293-082, A47293-083, A47293-084, A47293-085, A47293-086, A47293-087, A47293-088, A47293-089, A47293-090, A47293-091, A47293-092, A47293-093, A47293-094, A47293-095, A47293-096, A47293-097, A47293-098, A47293-099, A47293-100, A47293-101, A47293-102, A47293-103, A47293-104, A47293-105, A47293-106, A47293-107, A47293-108, A47293-109, A47293-110, A47293-111, A47293-112, A47293-113, A47293-114, A47293-115, A47293-116, A47293-117, A47293-118, A47293-119, A47293-120, A47293-121, A47293-122, A47293-123, A47293-124, A47293-125, A47293-126, A47293-127, A47293-128, A47293-129, A47293-130, A47293-131, A47293-132, A47293-133, A47293-134, A47293-135, A47482-026, A47482-027, A47482-028, A47482-029, A47482-030, A47482-031, A47482-032, A47482-033, A47482-034, A47482-035, A47482-036, A47482-037, A47482-038, A47482-039, A47482-040, A47482-042, A47482-043, A47482-044, A47482-045, A47482-046, A47482-047, A47482-048, A47482-049, A47482-050, A47482-051, A47482-052, A47482-053, A47482-054, A47482-055, A47482-056, A47482-057, A47482-058, A47482-059, A47482-060, A47482-061, A47482-062, A47482-063, A47482-064, A47482-065, A47482-066, A47482-067, A47482-068, A47482-069, A47482-070, A47482-071, A47482-072, A47482-073, A47482-074, A47482-075, A47482-076, A47482-077, A47482-078, A47482-079, A47482-080, A47482-082, A47482-083, A47482-084, A47482-085, A47482-086, A47482-087, A47482-088, A47482-089, A47482-090, A47482-091, A48188-011, A48188-012, A48188-013, A48188-014, A48188-015, A48188-016, A48188-017, A48188-018, A48188-019, A48188-020, A48188-021, A48188-022, A48188-023, A48188-024, A48188-025, A48188-026, A48188-027, A48188-028, A48188-029, A48188-030, A48188-031, A48188-032, A48188-033, A48188-034, A48188-035, A48188-036, A48188-037, A48188-038, A48188-039, A48188-040, A48188-041, A48188-042, A48188-043, A48188-044, A48188-045, A48188-046, A48188-047, A48188-048, A48188-049, A48188-050, A48188-051, A48188-052, A48188-053, A48188-054, A48188-055, A48188-056, A48538-151, A48538-152, A48538-153, A48538-154, A48538-155, A48538-156, A48538-157, A48538-158, A48538-159, A48538-160, A48538-161, A48538-162, A48538-163, A48538-164, A48538-165, A48538-166, A48538-167, A48538-168, A48538-169, A48538-170, A48538-171, A48538-172, A48538-173, A48538-174, A48538-175, A48538-176, A48538-177, A48538-178, A48538-179, A48538-180, A48538-181, A48538-182, A48538-183, A48538-184, A48538-185, A48538-186, A48538-187, A48538-188, A48538-189, A48538-190, A48538-191, A48538-192, A48538-193, A48538-194, A48538-195, A48538-196, A48538-197, A48538-198, A48538-199, A48538-200, A48538-201, A48538-202, A48538-203, A48538-204, A48538-205, A48538-206, A48538-207, A48538-208, A48538-209, A48538-210, A48538-211, A48538-212, A48538-213, A48538-214, A48538-215, A48538-216, A48538-217, A48538-218, A48538-219, A48538-220, A48538-221, A48538-222, A48538-223, A48538-224, A48538-225, A48538-226, A48538-227, A48538-228, A48538-229, A48538-230, A48538-231, A48538-232, A48538-233, A48538-234, A48538-235, A48538-236, A48538-237, A48538-238, A48538-239, A48538-240, A48538-241, A48538-242, A48538-243, A48538-244, A48538-245, A48538-246, A48538-247, A48538-248, A48538-249, A48538-250, A48538-251, A48538-252, A48672-036, A48672-037, A48672

Other Recalls from Medtronic Sofamor Danek USA Inc

Recall # Classification Product Date
Z-0580-2026 Class II Catalyft PL & PL40 Expandable Interbody System ... Sep 16, 2025
Z-0162-2024 Class II Grafton DBM (Flex), Model Numbers: T42100, Demi... Sep 26, 2023
Z-0165-2024 Class II Grafton DBM Orthoblend, Model Numbers: a) T4412... Sep 26, 2023
Z-0166-2024 Class II Grafton Plus DBM Paste, Model Numbers: a) T4500... Sep 26, 2023
Z-0167-2024 Class II Grafton DBM Putty, Model Numbers: a) T43102, b)... Sep 26, 2023

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Medtronic Sofamor Dane... Recalls by Firm Recall Reasons Device Safety Stats