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Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S...

FDA Device Recall #Z-1326-2023 — Class II — February 8, 2023

Recall Summary

Recall Number Z-1326-2023
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 30541 units

Product Description

Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT; h) DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF, REF T44135; i) DBM T44135INT 15CC GRAFTON ORTHOBLEND LG, REF T44135INT; j) DBM T44145 5CC ORTHOBLEND SMALL DEFGRAFT, REF T44145; k) DBM T44145AUS 5CC GRAFTON ORTHOBLEND SM, REF T44145AUS; l) DBM T44145INT 5CC GRAFTON ORTHOBLEND SM, REF T44145INT; m) DBM T44150 10CC ORTHOBLEND SMALL DEFGRAF, REF T44150; n) DBM T44150AUS 10CC GRAFTON ORTHOBLEND SM, REF T44150AUS; o) DBM T44150INT 10CC GRAFTON ORTHOBLEND SM, REF T44150INT; 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 S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125, GTIN 00613994961075, Serial Numbers: A47433, A48675; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135, GTIN 00613994961068, Serial Numbers: A42664; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145, GTIN 00613994961051, Serial Numbers: A40910, A48944, A52283; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150, GTIN 00613994961044, Serial Numbers: A43743; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125, GTIN 00643169122901, Serial Numbers: A41627-069, A41627-070, A41627-071, A41627-072, A41627-073, A41627-074, A41627-076, A41627-077, A41627-078, A41627-079, A41627-080, A41627-081, A41627-083, A41627-085, A41627-087, A41627-088, A41627-089, A41627-092, A41627-093, A41627-094, A41627-095, A41755-053, A41755-054, A41755-055, A41755-056, A41755-057, A41755-058, A41755-059, A41755-060, A41755-061, A41755-062, A41755-063, A41755-064, A41755-065, A41755-066, A41755-067, A41755-068, A41755-071, A41755-072, A41755-073, 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A51168-045, A51168-046, A51168-047, A51168-048, A51168-049, A51168-050, A51977-214, A51977-215, A51977-216, A51977-217, A51977-218, A51977-219, A51977-220, A51977-221, A51977-222, A52744-027, A52744-028, A52744-029, A52744-030, A52744-031, A52744-032, A52744-033, A52744-034, A52744-035, A52744-036, A52744-037, A52744-038, A52744-039, A52744-040, A52744-041, A52744-042, A52744-043, A52744-044, A52744-045, A52744-046, A52744-047, A52744-048, A52744-049, A53750-193, A53750-194, A53750-195, A53750-196, A53750-198, A53750-200, A53750-209, A53750-212, A53750-213, A53750-214, A53750-235, A53750-236, A53750-237, A53750-238, A53750-239, A53750-240, A53750-243, A53750-244, A53750-245, A53750-246, A53750-247; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS, GTIN 00643169431027, Serial Numbers: A42115-061, A42115-062, A42115-063, A44487-057, A44487-058, A44487-059, A44487-060, A44487-061, A44487-062, A44487-063, A44487-064, A44487-065, A44487-066, A44487-067, A44487-068, A46117-055, A46117-056, A46117-057, A46117-058, A46117-059, A47598-134, A47598-135, A47598-136, A47598-138, A47598-139, A47598-140, A47598-141, A47598-142, A47598-143, A49862-054, A49862-055; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT, GTIN 00643169965058, Serial Numbers: A38959-090, A38959-091, A38959-092, A38959-093, A38959-094, A38959-095, A38959-096, A38959-097, A38959-098, A38959-099, A38959-100, A38959-101, A38959-102, A38959-103, A38959-104, A38959-105, A38959-106, A38959-107, A38959-108, A38959-109, A38959-110, A38959-111, A38959-112, A40657-034, A40657-035, A40657-036, A40657-037, A40657-038, A40657-039, A40657-040, A40657-041, A40657-042, A40657-043, A40657-044, A40657-045, A40657-046, A40657-047, A40657-048, A40657-049, A40657-050, A40657-051, A40657-052, A40657-053, A40657-054, A40657-055, A40657-056, A40657-057, A40657-058, A40657-059, A40657-060, A40657-061, A40657-062, A40657-063, A40657-064, A40657-065, A40657-066, A40657-067, A40657-068, A40657-069, A40657-070, 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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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