This is part of a larger recall. The most authoritative record is FDA-Device / Z-0137-2027.
Medtronic Grafton DBM bone graft products recalled for potential Clostridium infection risk
What this means
Medtronic identified that donor tissue used in batch A62881 of Grafton DBM bone graft products tested positive for Clostridium butyricum bacteria and did not meet donor eligibility standards. Although the finished product passed sterility testing and underwent radiation treatment, there is a possibility of Clostridium infection if the product is implanted. Medtronic is retrieving all unused product from this batch.
- Check if you have Grafton DBM product with batch numbers A62881-014 through A62881-033
- Do not use or implant any product from the affected batch
- Contact your healthcare provider or Medtronic if you have received this product
- Return any unused product to the facility where it was obtained
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-0138-2027Want us to check the next one for you?
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