Recall Z-0138-2027 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medtronic Sofamor Danek USA Inc
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 f
| Date | Oct 9, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | On 8/12/2026, recall notices were mailed or emailed to customers who were asked to do the following: 1) Identify and quarantine any unused impacted product(s). 2) Return affected product(s) per the return instructions in the enclosed Customer Confirmation Form. If product was purchased directly from Medtronic please contact: rs.sdmrarequest@medtronic.com, 3) For patients already implanted with affected products, consider potential Clostridium infection if the patient presents with signs or symptoms of infection. If a patient develops an infection with clostridium at a remote site, evaluate the |
| Quantity | 20 |
| Distribution | US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA. |
| FDA record | Open on fda.gov |