Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert...
FDA Device Recall #Z-0138-2027 - Class II, August 12, 2026
Recall Summary
| Recall Number | Z-0138-2027 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 12, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Sofamor Danek USA Inc |
| Location | Memphis, TN |
| Product Type | Devices |
| Quantity | 20 |
Product Description
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are produced from a fiber form of DBM Crunch" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.
Reason for Recall
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.
Distribution Pattern
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
Lot / Code Information
UDI-DI: 00643169122932. Serial Numbers: A62881-014 through A62881-033, specifically: A62881-014, A62881-015, A62881-016, A62881-017, A62881-018, A62881-019, A62881-020, A62881-021, A62881-022, A62881-023, A62881-024, A62881-025, A62881-026, A62881-027, A62881-028, A62881-029, A62881-030, A62881-031, A62881-032, A62881-033
Other Recalls from Medtronic Sofamor Danek USA Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0137-2027 | Class II | Grafton" DBM and Grafton Plus" DBM contain demi... | Aug 12, 2026 |
| 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-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.