Medtronic Grafton DBM bone graft recalled for potential bacterial infection risk
What this means
Medtronic identified that donor tissue used in one batch of Grafton DBM bone graft products did not meet donor eligibility requirements and tested positive for Clostridium butyricum bacteria. Although the finished product passed sterility testing and the tissue underwent gamma radiation, there is a possibility of infection if the product is implanted. Medtronic is retrieving all unused product from this batch.
- If you have unused Grafton DBM product with serial numbers A62881-034 through A62881-051, do not use it.
- Contact Medtronic or your healthcare provider with your product lot number for return instructions.
- If you received an implant from this batch, contact your surgeon or healthcare provider.
The agency's original wording
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2027Also reported as
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