Z-0138-2027 Class II Ongoing
FDA device recall Z-0138-2027 was initiated by Medtronic Sofamor Danek USA Inc on Aug 12, 2026 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Aug 12, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
Code Information
UDI-DI: 00643169122932. Serial Numbers: A62881-014 through A62881-033, specifically: A62881-014, A62881-015, A62881-016, A62881-017, A62881-018, A62881-019, A62881-020, A62881-021, A62881-022, A62881-023, A62881-024, A62881-025, A62881-026, A62881-027, A62881-028, A62881-029, A62881-030, A62881-031, A62881-032, A62881-033
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0138-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026