Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts
Grafton DBM and Grafton Plus DBM may cause infection if implanted.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Medtronic Sofamor Danek USA Inc. recalled Grafton DBM and Grafton Plus DBM products manufactured from donor tissue in a batch, because the donor did not meet all donor eligibility requirements related to the presence of microbial organisms. The recall began August 12, 2026, and was added to the FDA's Enforcement Report on October 9, 2026. Medtronic is retrieving any unused product manufactured from the donor tissue.
Summary by Recall Canary from the FDA notice.
What to do
If a code on your device matches:
- While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue.
Is your can affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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.
- UDI-DI
- 00643169122932
Details
- Company began the recall
- Event ID
- 99701
- Company
- Medtronic Sofamor Danek USA Inc
- Hazard
- Sterility failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
