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Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1...

FDA Device Recall #Z-1325-2023 — Class II — February 8, 2023

Recall Summary

Recall Number Z-1325-2023
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 2987 units

Product Description

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS; i) DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT; j) DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT; 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 S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A44616-020, A44616-021, A44616-022, A44616-023, A44616-024, A44616-025, A44616-026, A44616-027, A44616-028, A44616-029, A44616-030, A44616-031, A44616-032, A44616-033, A44616-034, A44616-035, A44704-011, A44704-012, A44704-013, A44704-014, A44704-015, A44704-016, A44704-017, A44704-018, A44704-019, A44704-020, A44704-021, A44704-022, A44704-023, A44704-024, A45275-011, A45275-012, A45275-013, A45275-014, A45275-015, A45275-016, A45275-017, A45275-018, A45275-019, A45275-020, A45275-021, A45275-022, A45275-023, A45275-024, A45275-025, A45275-026, A45275-027, A45275-028, A45275-029, A45275-030, A45275-031, A45275-032, A45275-033, A45275-034, A45275-035, A45544-011, A45544-012, A45544-013, A45544-014, A45544-015, A45544-016, A45544-017, A45544-018, A45544-019, A45544-020, A45544-021, A45544-022, A45544-023, A45544-024, A45544-025, A46162-011, A46162-012, A46162-013, A46162-014, A46162-015, A46162-016, A46162-017, A46162-018, A46162-019, A46162-020, A46162-021, A46162-022, A46162-023, A46162-024, A46537-011, A46537-012, A46537-013, A46537-014, A46537-015, A46537-016, A46537-017, A46537-018, A46537-019, A46537-020, A46537-021, A46537-022, A46537-023, A46537-024, A46537-025, A46537-026, A46711-024, A46711-025, A46711-026, A46711-027, A46711-028, A46711-029, A46711-030, A46711-031, A46711-032, A46711-033, A46711-034, A46711-035, A46711-036, A46711-037, A47573-011, A47573-012, A47573-013, A47573-014, A48312-011, A48312-012, A48312-013, A48312-014, A48312-015, A48312-016, A48312-017, A48312-018, A48312-019, A48472-011, A48472-012, A48472-013, A48472-014, A48472-015, A48472-016, A48472-017, A48472-018, A48472-019, A48472-020, A48472-021, A48472-022, A48759-011, A48759-012, A48759-013, A48759-014, A48759-015, A48759-016, A48759-017, A48759-018, A48759-019, A48759-020, A48759-021, A48759-023, A48759-024, A48759-025, A48759-026, A49927-011, A49927-012, A49927-013, A49927-014, A49927-015, A49927-016, A49927-017, A49927-018, A49927-019, A49927-020, A49927-021, A49927-022, A49927-023, A51087-011, A51087-012, A51087-013, A51087-014, A51087-015, A51087-016, A51087-017, A51087-018, A51102-054, A51102-055, A51102-056, A51102-057, A51102-058, A51102-059, A51102-060, A51102-061, A52712-082, A52712-083, A52712-084, A52712-085, A52712-086, A52712-087, A52712-088, A52712-089, A52712-090, A52712-091, A52712-092, A52712-093, A52712-094, A52712-095, A52712-096, A52712-097, A52712-098, A52712-099, A52712-100, A53148-011, A53148-012, A53148-013, A53148-014, A53148-015, A53284-026, A53284-027, A53284-028, A53284-029, A53284-030, A53284-031, A53284-032, A53284-033, A53284-034, A53284-035, A53284-036, A53284-037, A53284-038, A53284-039, A53284-040, A53284-041, A53284-042, A53284-043, A53284-044, A53284-045, A53284-046, A53770-011, A53770-012, A53770-013, A53770-014, A53770-015, A53770-016, A53770-017, A53770-018, A53770-019, A53770-020, A53770-021, A53770-022, A53770-023, A54399-043, A54399-044, A54399-045, A54399-046, A54399-047, A54399-048, A54399-049, A54399-050, A54399-051, A54399-052, A54399-053, A54399-054, A54399-055, A54399-056, A54399-057, A55095-050, A55095-051, A55095-052, A55095-053, A55095-054, A55095-055, A55095-056, A55095-057, A55095-058, A55095-059, A55095-060, A55095-061, A55095-062, A55095-063, A55095-064, A55095-065, A55095-066, A55095-067; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT, GTIN 00643169964877, Serial Numbers: A42232-041, A42232-042, A42232-043, A42232-044, A42232-045, A42232-046, A42232-047, A42232-048, A42232-049, A42232-050, A42232-051, A42232-052, A42232-053, A42232-054, A42232-055, A42232-056, A42232-057, A42232-058, A42232-059, A42232-060, A42232-061, A42232-062, A42232-063, A42851-038, A42851-039, A42851-040, A42851-041, A42851-042, A42851-043, A42851-044, A42851-045, A42851-046, A42851-047, A42851-048, A42851-049, A42851-050, A42851-051, A42851-052, A43708-049, A43708-050, A43708-051, A43708-052, A43708-053, A43708-054, A43708-055, A43708-056, A43708-057, A43708-058, A43708-059, A43708-060, A43708-061, A43708-062, A43708-063, A43708-064, A43708-065, A43708-066, A43708-067, A43708-068, A43708-069, A43708-070, A43708-071, A43708-072, A43708-073, A43708-074, A43708-075, A43708-076, A43708-077, A43708-078, A43708-079, A43708-080, A43708-082, A43708-083, A43708-084, A43708-085, A43708-086, A43708-087, A43708-088, A43708-089, A43708-090, A43708-092, A43708-093, A43708-094, A43708-095, A43708-096, A43708-099, A43708-101, A43708-102, A43708-103, A43708-104, A44398-011, A44398-012, A44398-013, A44398-014, A44398-015, A44398-016, A44398-017, A44398-018, A44398-019, A44398-020, A44398-021, A44398-022, A44398-023, A44398-024, A44398-025, A44398-026, A44398-027, A44398-028, A44398-029, A44398-030, A44398-031, A44398-032, A44398-033, A44398-034, A44398-035, A44704-025, A44704-026, A44704-027, A44704-028, A44704-029, A44704-030, A44704-031, A44704-032, A44704-033, A44704-034, A44704-035, A44704-036, A44704-037, A44704-038, A45772-011, A45772-012, A45772-013, A45772-014, A45772-015, A45826-011, A45826-012, A45826-013, A45826-014, A45898-023, A45898-024, A45898-025, A45898-026, A47573-029, A47832-021, A48759-039, A52104-039, A52104-040, A52104-041, A52104-042, A52104-043, A52104-044, A52104-045, A52104-047, A52104-048, A52104-049, A52104-050, A52104-051, A52104-052, A52104-053, A52104-054, A52104-055, A53050-011, A53050-012, A53050-013, A53050-014, A53050-015, A53050-016, A53050-017, A53050-018, A53050-019, A53050-020, A55429-021; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100, GTIN 00643169123007, Serial Numbers: A41864-011, A41864-012, A41864-013, A41864-014, A41864-015, A41864-016, A41864-017, A41864-018, A41864-019, A41864-020, A41864-021, A42890-025, A42890-026, A42890-027, A42890-028, A42890-029, A42890-030, A42890-031, A42890-032, A42890-033, A42890-034, A42890-035, A42890-036, A42890-037, A42890-038, A42964-021, A42964-022, A42964-023, A42964-024, A42964-025, A42964-026, A42964-027, A42964-028, A42964-029, A42972-061, A42972-062, A42972-063, A42972-064, A42972-065, A42972-066, A42972-067, A42972-068, A42972-069, A42972-070, A42972-071, A42972-072, A42972-073, A42972-074, A42972-075, A42972-076, A43119-106, A43119-107, A43119-108, A43119-109, A43119-110, A43119-111, A43119-112, A43119-113, A43119-114, A43119-115, A43119-116, A43119-117, A43119-118, A43155-016, A43155-017, A43155-018, A43155-019, A43155-020, A43155-021, A43155-022, A43155-023, A43155-024, A43155-025, A43155-026, A43281-030, A43281-031, A43281-032, A43281-033, A43281-034, A43281-035, A43281-036, A43281-037, A43281-038, A43281-039, A43281-040, A43403-011, A43403-012, A43403-013, A43403-014, A43403-015, A43403-016, A43403-017, A43403-018, A43403-019, A43403-020, A43403-021, A43403-022, A43403-023, A43403-024, A43403-025, A43708-105, A43708-106, A43708-107, A43708-108, A43708-109, A43708-110, A44100-011, A44100-012, A44100-013, A44100-014, A44100-015, A44100-016, A44100-017, A44100-018, A44100-019, A44100-020, A44100-021, A44100-022, A44100-023, A44100-024, A44100-025, A44118-011, A44118-012, A44118-013, A44118-014, A44118-015, A44118-016, A44118-017, A44118-018, A44118-019, A44118-020, A44118-021, A44118-022, A44118-023, A44118-024, A44290-011, A44290-012, A44290-013, A44290-014, A44290-015, A44290-016, A44290-017, A44290-018, A44290-019, A44290-020, A44290-021, A44290-022, A44290-023, A44290-024, A44290-025, A44290-026, A44311-011, A44311-012, A44311-013, A44311-014, A44311-015, A44311-016, A44311-017, A44311-018, A44311-019, A44311-020, A44311-021, A44311-022, A44311-023, A44311-024, A44311-025, A44372-129, A44372-130, A44372-131, A44372-132, A44372-133, A44372-134, A44372-135, A44372-136, A44372-137, A44372-138, A44372-139, A44372-140, A44372-141, A44372-142, A44372-143, A44412-060, A44412-061, A44412-062, A44412-063, A44412-064, A44412-065, A44412-066, A44412-067, A44412-068, A44412-069, A44412-070, A44412-071, A44412-072, A44412-073, A44412-074, A44655-046, A44655-047, A44655-048, A44655-049, A44655-050, A44655-051, A44655-052, A44655-053, A44655-054, A44655-055, A44655-056, A44655-057, A44655-058, A44764-011, A44764-012, A44764-013, A44764-014, A44764-015, A44764-016, A44764-017, A44764-018, A44764-019, A44764-020, A45256-011, A45256-012, A45256-013, A45256-014, A45256-015, A45256-016, A45256-017, A45256-018, A45256-019, A45256-020, A45256-021, A45256-022, A45256-023, A45256-024, A45256-025, A45281-117, A45281-118, A45281-119, A45281-120, A45281-121, A45281-122, A45281-123, A45281-124, A45281-125, A45281-126, A45281-127, A45281-128, A45281-129, A45281-130, A45281-131, A45512-011, A45512-012, A45521-011, A45521-012, A45521-013, A45521-014, A45521-015, A45521-016, A45521-017, A45521-018, A45521-019, A45521-020, A45521-021, A45521-022, A45521-023, A45521-024, A45521-025, A45521-026, A45544-026, A45544-027, A45544-028, A45544-029, A45544-030, A45544-031, A45544-032, A45544-033, A45544-034, A45544-035, A45544-036, A45544-037, A45544-038, A45544-039, A45572-033, A45572-034, A45572-035, A45572-036, A45572-037, A45572-038, A45572-039, A45572-040, A45572-041, A45572-042, A45572-043, A45572-044, A45572-045, A45572-046, A45572-047, A45579-021, A45579-022, A45579-023, A45579-024, A45579-025, A45579-026, A45579-027, A45579-028, A45579-029, A45579-030, A45579-031, A45579-032, A45579-033, A45579-034, A45579-035, A45581-036, A45581-037, A45581-038, A45581-039, A45581-040, A45581-041, A45581-042, A45581-043, A45581-044, A45581-045, A45581-046, A45581-047, A45581-048, A45581-049, A45581-050, A45581-051, A45703-011, A45703-012, A45703-013, A45703-014, A45703-015, A45703-016, A45703-017, A45703-018, A45703-019, A45703-020, A45703-021, A45703-022, A45703-023, A45703-024, A45703-025, A45703-026, A45970-011, A45970-012, A45970-013, A45970-014, A45970-015, A45970-016, A45970-017, A45970-018, A45970-019, A45970-020, A45970-021, A45970-022, A45970-023, A45970-024, A45970-025, A45970-026, A46023-031, A46023-032, A46023-033, A46023-034, A46023-035, A46023-036, A46023-037, A46023-038, A46023-039, A46023-040, A46023-041, A46023-042, A46044-058, A46044-059, A46044-060, A46044-061, A46044-062, A46044-063, A46044-064, A46044-065, A46044-066, A46044-067, A46044-068, A46044-069, A46044-070, A46044-071, A46162-025, A46162-026, A46162-027, A46162-028, A46162-029, A46162-030, A46162-031, A46162-032, A46162-033, A46162-034, A46162-035, A46162-036, A46162-037, A46162-038, A46537-027, A46537-028, A46537-029, A46537-030, A46537-031, A46537-032, A46537-033, A46537-034, A46537-035, A46537-036, A46537-037, A46537-038, A46537-039, A46537-040, A46537-041, A46537-042, A46537-043, A46537-044, A46537-045, A46537-046, A46537-047, A46537-048, A46537-049, A46537-050, A46552-011, A46552-012, A46552-013, A46552-014, A46552-015, A46552-016, A46552-017, A46552-018, A46552-019, A46552-020, A46552-021, A46552-022, A46552-023, A46552-024, A46583-011, A46583-012, A46583-013, A46583-014, A46583-015, A46583-016, A46583-017, A46583-018, A46583-019, A46583-020, A46583-021, A46711-038, A46711-039, A46711-040, A46711-041, A46711-042, A46711-043, A46711-044, A46711-045, A46711-046, A46711-047, A46711-048, A46711-049, A46711-050, A46711-051, A46711-052, A46711-053, A46711-054, A46711-055, A46711-056, A46711-057, A46711-058, A46711-059, A46849-127, A46849-129, A46849-130, A46849-131, A46849-132, A46849-133, A46849-134, A46849-135, A46849-136, A46891-042, A46891-043, A46891-044, A46891-045, A46891-046, A46991-031, A46991-032, A46991-033, A46991-034, A46991-035, A46991-036, A46991-037, A46991-038, A46991-039, A46991-040, A46991-041, A46991-042, A46991-043, A46991-044, A46991-045, A47264-011, A47264-012, A47264-013, A47264-014, A47264-015, A47264-016, A47264-017, A47264-018, A47264-019, A47264-020, A47264-021, A47264-022, A47264-023, A47264-024, A47264-025, A47264-026, A47264-027, A47264-028, A47264-029, A47264-030, A47264-031, A47264-032, A47264-033, A47264-034, A47264-035, A47264-036, A47264-037, A47264-038, A47264-039, A47264-040, A47264-041, A47293-136, A47293-137, A47293-138, A47293-139, A47293-140, A47293-141, A47293-142, A47293-143, A47293-144, A47293-145, A47293-146, A47293-147, A47293-148, A47293-149, A47293-150, A47345-011, A47345-012, A47345-013, A47345-014, A47345-015, A47345-016, A47345-017, A47345-018, A47345-019, A47345-020, A47345-021, A47345-022, A47345-023, A47345-024, A47345-025, A47345-026, A47345-027, A47345-028, A47345-029, A47345-030, A47345-031, A47345-032, A47345-033, A47345-034, A47345-035, A47345-036, A47345-037, A47345-038, A47369-011, A47369-012, A47369-013, A47369-014, A47369-015, A47369-016, A47369-017, A47369-018, A47369-019, A47369-020, A47369-021, A47369-022, A47369-023, A47369-024, A47514-024, A47514-025, A47514-026, A47514-027, A47514-028, A47514-029, A47514-030, A47514-031, A47573-015, A47573-016, A47573-017, A47573-018, A47573-019, A47573-020, A47573-021, A47573-022, A47573-023, A47573-024, A47573-025, A47573-026, A47573-027, A47573-028, A47577-036, A47577-037, A47577-038, A47577-039, A47577-040, A47577-041, A47577-042, A47577-043, A47577-044, A47577-045, A47577-046, A47577-047, A47577-048, A47577-049, A47577-050, A47577-051, A47590-029, A47590-030, A47590-031, A47590-032, A47590-033, A47590-034, A47590-035, A47590-036, A47590-037, A47590-038, A47590-039, A47590-040, A47590-041, A47590-042, A47864-017, A47864-018, A47864-019, A47864-020, A47864-021, A47864-022, A47864-023, A47864-024, A47864-025, A47864-026, A47864-027, A47864-028, A47864-029, A47864-030, A47864-031, A47864-032, A47864-033, A47864-034, A47864-035, A47864-036, A47864-037, A47864-038, A47864-039, A47864-040, A47864-041, A48052-011, A48052-012, A48052-013, A48052-014, A48052-015, A48052-016, A48052-017, A48052-018, A48052-019, A48052-020, A48052-021, A48052-022, A48052-023, A48052-024, A48154-011, A48154-012, A48154-013, A48154-014, A48154-015, A48154-016, A48154-017, A48154-018, A48154-019, A48154-020, A48154-021, A48234-011, A48234-012, A48234-013, A48234-014, A48234-016, A48234-017, A48234-018, A48234-019, A48234-020, A48234-021, A48234-022, A48234-023, A48234-024, A48472-023, A48472-024, A48472-025, A48472-026, A48472-027, A48472-028, A48472-029, A48472-030, A48472-031, A48472-032, A48472-033, A48472-034, A48556-011, A48556-012, A48556-013, A48556-014, A48556-015, A48556-016, A48556-017, A48556-018, A48556-019, A48556-020, A48556-021, A48573-077, A48573-078, A48573-079, A48573-080, A48573-081, A48573-082, A48573-083, A48573-084, A48573-085, A48573-086, A48573-087, A48573-088, A48573-089, A48573-090, A48573-091, A48573-092, A48689-011, A48689-012, A48689-013, A48689-014, A48689-015, A48689-016, A48689-017, A48689-018, A48689-019, A48689-020, A48689-021, A48689-022, A48759-027, A48759-028, A48759-029, A48759-030, A48759-031, A48759-032, A48759-033, A48759-034, A48759-035, A48759-036, A48759-037, A48759-038, A48941-011, A48941-012, A48941-013, A48941-014, A48941-015, A48941-016, A48941-017, A48941-018, A48941-019, A48941-020, A48941-021, A49861-049, A49861-050, A49861-052, A49861-053, A49861-054, A49861-055, A49861-056, A49861-057, A49861-058, A49861-059, A49861-060, A49861-061, A49861-063, A49861-064, A49861-065, A49861-066, A49861-067, A49861-068, A49861-069, A49861-070, A49861-071, A49861-072, A49861-073, A49861-074, A49930-011, A49930-012, A49930-013, A49930-014, A49930-015, A49930-016, A49930-017, A49930-018, A49930-019, A49930-020, A49930-021, A50118-011, A50118-012, A50118-013, A50118-014, A50118-015, A50118-016, A50118-017, A50118-018, A50118-019, A50118-020, A50118-021, A50118-022, A50118-023, A50118-024, A50118-025, A50281-011, A50281-012, A50281-013, A50281-014, A50281-015, A50281-016, A50281-017, A50281-018, A50281-019, A50281-020, A50281-021, A50281-022, A50281-023, A50281-024, A50281-025, A50329-011, A50329-012, A50329-013, A50329-014, A50329-015, A50360-011, A50360-012, A50360-013, A50360-014, A50360-015, A50360-018, A50360-020, A50360-021, A50360-022, A50360-023, A50360-024, A51087-019, A51087-020, A51087-021, A51087-022, A51087-023, A51087-024, A51087-025, A51087-026, A51087-027, A51087-028, A51087-029, A51087-030, A51087-031, A51087-032, A51723-011, A51723-012, A51723-013, A51723-014, A51723-015, A51723-016, A51723-017, A51723-018, A51723-019, A51723-020, A51723-021, A51723-022, A51723-023, A51723-024, A51723-025, A51978-026, A51978-027, A51978-028, A51978-029, A51978-030, A51978-031, A51978-032, A51978-033, A51978-034, A51978-035, A51978-036, A51978-037, A51992-011, A51992-012, A51992-013, A51992-014, A51992-015, A51992-016, A51992-017, A51992-018, A51992-019, A51992-020, A51992-021, A51992-022, A51992-023, A51992-024, A51992-025, A52104-056, A52104-057, A52104-058, A52104-059, A52104-060, A52104-061, A52104-062, A52104-063, A52174-011, A52174-012, A52174-013, A52174-015, A52283-052, A52283-053, A52283-054, A52283-055, A52283-056, A52283-057, A52283-058, A52283-059, A52283-060, A52283-061, A52283-062, A52283-063, A52283-064, A52283-065, A52283-066, A52510-011, A52510-012, A52510-013, A52510-014, A52510-015, A52510-016, A52510-017, A52510-018, A52510-019, A52510-020, A52510-021, A52510-022, A52510-023, A52510-024, A52510-025, A52981-041, A52981-042, A52981-043, A52981-044, A52981-045, A52981-046, A52981-047, A52981-048, A52981-050, A52981-051, A52981-052, A52981-053, A52981-054, A52981-055, A52981-056, A52981-057, A52981-058, A52981-059, A52981-060, A52981-061, A52981-062, A52981-063, A52981-064, A52981-065, A52981-066, A52981-067, A53050-021, A53050-022, A53050-023, A53050-024, A53050-025, A53050-026, A53050-027, A53050-028, A53050-029, A53050-030, A53050-031, A53050-032, A53082-011, A53082-012, A53082-013, A53082-014, A53082-015, A53082-016, A53082-017, A53082-018, A53082-019, A53082-020, A53082-021, A53082-022, A53082-023, A53082-024, A53082-025, A53133-179, A53133-180, A53133-181, A53133-182, A53133-183, A53133-184, A53133-185, A53133-186, A53133-187, A53133-188, A53133-189, A53133-190, A53133-191, A53133-192, A53148-016, A53148-017, A53148-018, A53148-019, A53148-020, A53148-021, A53148-022, A53148-023, A53148-024, A53148-025, A53148-026, A53148-027, A53148-028, A53148-029, A53181-044, A53181-045, A53181-046, A53181-047, A53181-048, A53181-049, A53181-050, A53181-051, A53181-052, A53181-053, A53181-054, A53181-055, A53181-056, A53181-057, A53181-058, A53181-059, A53284-047, A53284-048, A53284-049, A53284-050, A53284-051, A53284-052, A53284-053, A53284-054, A53284-055, A53284-056, A53284-057, A53284-058, A53284-059, A53349-084, A53349-085, A53349-086, A53349-087, A53349-088, A53349-089, A53349-090, A53349-091, A53349-092, A53349-093, A53770-024, A53770-025, A53770-026, A53770-027, A53770-028, A53770-029, A53770-030, A53813-051, A53813-052, A53813-053, A53813-054, A53813-055, A53813-056, A53813-057, A53813-058, A53813-059, A53813-060, A53813-061, A53813-062, A53813-063, A53813-064, A54163-028, A54163-029, A54293-021, A54293-022, A54293-023, A54399-031, A54399-032, A54399-033, A54399-034, A54399-035, A54399-036, A54399-037, A54399-038, A54399-039, A54399-040, A54399-041, A54399-042, A54654-011, A54654-012, A54654-013, A54654-014, A54654-015, A54654-016, A54654-017, A54654-018, A54654-019, A54654-020, A54654-021, A54654-022, A54654-023, A54654-024, A54654-025, A54654-026, A54779-011, A54779-012, A54779-013, A54779-014, A54779-015, A54779-016, A54779-017, A54779-018, A54779-019, A54779-020, A54779-021, A54779-022, A54779-023, A54783-013, A54783-014, A54783-015, A54783-016, A54783-017, A54783-018, A54783-019, A54783-020, A54783-022, A54783-025, A54809-011, A54809-012, A54809-013, A54809-014, A54809-015, A54809-016, A54809-017, A54809-018, A54809-019, A54809-020, A54809-021, A54809-022, A54809-023, A54809-024, A54809-025, A54847-011, A54847-012, A54847-013, A54960-040, A54960-041, A54960-042, A54960-043, A54960-044, A54960-045, A54960-046, A54960-047, A54960-048, A54960-049, A54960-050, A54960-051, A54960-052, A54960-053, A55095-090, A55095-091, A55095-092, A55095-093, A55095-094, A55095-095, A55095-096, A55095-097, A55095-098, A55255-011, A55255-012, A55255-013, A55255-014, A55255-015, A55255-016, A55255-017, A55255-018, A55255-019, A55255-020, A55255-021, A55255-022, A55255-023, A55255-024, A55255-025, A55255-026, A55255-027, A55255-028, A55581-022, A55581-023, A55581-024, A55610-011, A55610-012, A55610-013, A55610-014, A55610-015, A55610-016, A55610-017, A55610-018, A55610-019, A55610-020, A55610-021, A55610-022, A55610-023, A55610-024; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS, GTIN 00643169430969, Serial Numbers: A43708-045, A43708-046, A43708-047, A43708-048, A43995-011, A43995-012, A43995-013, A43995-014, A43995-015, A43995-016, A43995-017, A43995-018, A43995-019, A43995-020, A43995-021, A43995-022, A43995-023, A43995-024, A43995-025, A43995-026, A43995-027, A43995-028, A43995-029, A43995-030, A43995-031, A43995-032, A43995-033, A43995-034, A43995-035, A43995-036, A43995-037, A43995-038, A43995-039, A43995-040, A43995-041, A44446-066, A44446-067, A44446-068, A44446-069, A44446-070, A44446-071, A44446-072, A44446-073, A44446-074, A44446-075, A44446-076, A44446-077, A44446-078, A44446-079, A44446-080, A44446-081, A44446-082, A44446-083, A44446-084, A44446-085, A44446-086, A44446-087, A44446-088, A44446-089, A44446-090, A44446-091, A44446-092, A44446-093, A44616-036, A44616-037, A44616-038, A44616-039, A44616-040, A44616-041, A44616-042, A44616-043, A44616-044, A44616-045, A44616-046, A44616-047, A45898-027, A45898-028, A45898-029, A45898-030, A45898-031, A45898-032, A45898-033, A45898-034, A45898-035, A45898-036, A45898-037, A45898-038, A45898-039, A45898-040, A46583-022, A46583-023, A46583-024, A46583-025, A46583-026, A46583-027, A46583-028, A46583-029, A46583-030, A46583-031, A46583-032, A46583-033, A46583-034, A46583-035, A46583-036, A46583-037, A46583-038, A46583-039, A46583-040, A46583-041, A47048-011, A47048-012, A47048-013, A47048-014, A47048-015, A47048-016, A47048-017, A47048-018, A47048-019, A47048-020, A47048-021, A47048-022, A47048-023, A47048-024, A47048-025, A47345-039, A47514-032, A47514-033, A47514-034, A47514-035, A47514-036, A47514-037, A47514-038, A48154-022, A48154-023, A48154-024, A48154-025, A48154-026, A50504-045, A50504-046, A50504-047, A50504-048, A50504-049, A50504-050, A50504-051, A50705-056, A50705-057, A50705-058, A50705-059, A50705-060, A50705-061, A50705-062, A50705-063, A50705-064, A50705-065, A50705-066, A50705-067, A50705-068, A50705-069, A50705-070, A50705-071, A50705-072, A50705-073, A50705-074, A50705-075, A50705-076, A50705-077, A50705-078, A50705-079, A50705-080, A50705-081, A50705-082, A50705-083, A50705-084, A52987-011, A52987-012, A52987-013, A52987-014, A52987-015, A52987-016, A52987-017, A52987-018, A52987-019, A52987-020, A52987-021, A52987-022, A52987-023, A52987-024; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT, GTIN 00643169964884, Serial Numbers: A41864-022, A41864-025, A43220-014, A43220-015, A43220-016, A43220-017, A43220-018, A43220-019, A43220-020, A43220-021, A43220-022, A43220-023, A43220-024, A43220-025, A43220-026, A43220-027, A46552-025, A46991-046, A47264-042, A49099-011, A49099-012, A49099-013, A49099-014, A49099-015, A51978-025, A52104-064, A52104-065, A52104-066, A52981-070, A53349-081, A53349-082, A53349-083, A54391-044, A55429-033, A55429-034, A55429-035, A55429-036, A55429-037, A55429-038, A55429-039, A55429-040, A55429-041, A55429-042; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110, GTIN 00643169123014, Serial Numbers: A40174-080, A40174-081, A40174-082, A40174-083, A40174-084, A40174-085, A40174-086, A40174-087, A40174-088, A40174-089, A40174-090, A40174-091, A40174-092, A40174-093, A40174-094, A40174-095, A40174-096, A40174-097, A40174-098, A40174-099, A40174-100, A40174-101, A40174-102, A40174-103, A41995-094, A41995-095, A41995-096, A41995-097, A41995-098, A41995-099, A41995-100, A41995-101, A41995-102, A41995-103, A41995-104, A41995-105, A41995-106, A41995-107, A41995-108, A41995-109, A41995-110, A41995-111, A41995-112, A41995-113, A41995-114, A41995-115, A41995-116, A41995-117, A42328-024, A42328-025, A42328-026, 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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.

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