Bone graft Recall: Medtronic Sofamor Danek USA Grafton DBM
The recall covers 18 units of bone graft products Grafton DBM and Grafton Plus DBM produced from demineralized human bone tissue; donor batch A62881 did not meet donor eligibility requirements due to the presence of microbial organisms, including Clostridium butyricum. Although the batch passed finished product sterility testing, there is a possibility of clostridium infection if implanted. Units were distributed nationwide in OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA; recall number UDI-DI 00643169123021 and serial numbers A62881-034 through A62881-051.
| Brand | Medtronic Sofamor Danek USA Inc |
|---|---|
| Product | 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 | 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 |
| Severity | moderate |
| Units affected | 20 |
| Distribution | US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use or implant the affected bone grafts; contact your surgeon or hospital immediately.
- If you or a patient has already received an implant, inform your surgeon and seek medical evaluation for signs of infection.
- Collect and keep the recall number (UDI-DI 00643169123021) and the affected serial numbers (A62881-034 to A62881-051) and share them with your healthcare team.
- For more information, contact Medtronic Sofamor Danek USA or the FDA recall information page.
How to identify the recalled item
| Lot / date codes | UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically: A62881-034, A62881-035, A62881-036, A62881-037, A62881-038, A62881-039, A62881-040, A62881-041, A62881-042, A62881-043, A62881-044, A62881-045, A62881-046, A62881-047, A62881-048, A62881-049, A62881-050, A62881-051 |
|---|---|
| Lot / date codes | 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 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other bone graft recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.