Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a de
Summary
The FDA issued a Class II for Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combi by Medtronic Sofamor Danek USA Inc. Reason: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements r.
Details
Source
Device Recall
External ID
Z-0138-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 20
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
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-12
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Medtronic Sofamor Danek USA Inc has 62 FDA actions in our database, including 37 recalls and 25 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Sofamor Danek USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Sofamor Danek USA Inc have FDA actions?
Medtronic Sofamor Danek USA Inc has 62 FDA actions in our database, including 37 recalls and 25 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0138-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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