Official recall record
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-08-12
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00643169123021
- Brand on record
- Medtronic Sofamor Danek USA Inc
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-11-12.
Other recalls from this brand
- 2026-08-12 · US FDA — Medical Devices
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to - 2023-09-26 · US FDA — Medical Devices
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical Devices
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matri
All 9 official recall notices naming Medtronic Sofamor Danek USA Inc on this site →