FDA Medical devices recall ·
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue… recall
- Recall number
- Z-0137-2027
- Date
- (initiated August 12, 2026)
- Company / brand
- Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl, Memphis, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18
- Hazard tags
- Botulism Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically: A62881-034, A62881-035, A62881-036, A62881-037, A62881-038, A62881-039, A62881-040, A62881-041, A62881-042, A62881-043, A62881-044, A62881-045, A62881-046, A62881-047, A62881-048, A62881-049, A62881-050, A62881-051
Distribution
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
States: Alabama Arkansas Colorado Delaware Florida Georgia Illinois Kansas Maryland Michigan Oklahoma Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0137-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.