Recall Z-0138-2027
- Recall number
- Z-0138-2027
- Event number
- 99701
- Firm
- Medtronic Sofamor Danek USA Inc
- Firm FEI
- 1000477302
- Product code
- MBP
- Status
- Open, Classified
- Initiated
- 2026-08-12
- Posted
- 2026-10-09
- Root cause
- Process change control
- 510(k) numbers
- K051188, K051195, K073329, K052735, K122513, K091193, K081817, K043209, K060794, K053642, K080329, K242799, K080399, K113728, K103742, K061668, K050806, K130498, K061131, K060180, K060161, K062205, K063685, K130703, K063676, K143547, K080405, K053098, K061982, K042829
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 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.