Stop using now Medical device recall · FDA · Published August 12, 2026

Grafton DBM and Grafton Plus DBM Recall: Risk of Clostridium Infection

Medtronic Sofamor Danek recalls 20 units of Grafton DBM and Grafton Plus DBM products due to potential Clostridium butyricum infection risk from donor tissue. Stop using immediately if you have the affected serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0138-2027Medical device Medtronic Sofamor Danek ›

Stop using this now

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.

✎ GovInfoNow plain-language explainer

Medtronic Sofamor Danek is recalling 20 units of Grafton DBM and Grafton Plus DBM products because donor tissue tested positive for Clostridium butyricum, a bacterium that could cause infection if implanted. The products were manufactured from donor tissue that did not meet safety requirements despite passing sterility tests. Read more at govinfonow.com/recall/1764901-medtronic-sofamor-danek-usa-inc-recalls-grafton-dbm-and-grafton.

Source Summary by GovInfoNow · govinfonow.com/recall/1764901-medtronic-sofamor-danek-usa-inc-recalls-grafton-dbm-and-grafton · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0138-2027

Cite this page

“Grafton DBM and Grafton Plus DBM Recall: Risk of Clostridium Infection.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764901-medtronic-sofamor-danek-usa-inc-recalls-grafton-dbm-and-grafton. Based on FDA recall #Z-0138-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2027%22&limit=1).

The FDA announced on Aug. 12, 2026, that Medtronic Sofamor Danek USA Inc is recalling Grafton DBM and Grafton Plus DBM products due to a potential clostridium infection risk. The agency said the recall covers specific serial numbers from batch A62881 distributed nationwide.

How to tell if you have it

Brand: Medtronic Sofamor Danek
Product: Grafton DBM and Grafton Plus DBM
UDI-DI: 00643169122932
Serial Numbers: A62881-014 through A62881-033

The hazard

Medtronic identified through donor record review that the donor for batch A62881 did not meet all donor eligibility requirements related to microbial organisms. Donor bone tissue tested positive for Clostridium butyricum, and while the tissue underwent gamma radiation, there is a possibility of clostridium infection if implanted.

Context

GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 20 other recalls on record since Dec. 6, 2017. Other recent recalls include the Sept. 16, 2025, recall of an expandable interbody system cage and the July 31, 2023, Magnifuse Bone Graft recall for incorrect labeling risk. Similar product recalls in 2026 include American Contract Systems Medical Kits on May 19, Medline Centurion Kits on March 19, and Medtronic DLP Retrograde Cannula on April 21.

How to tell if you have this one

Check for serial numbers A62881-014 through A62881-033 on the product packaging. The products are sold nationwide in states including Oklahoma, Virginia, Colorado, and others listed in the recall.

Brand
Medtronic Sofamor Danek
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.

Recall number	Product, codes & lots	Quantity
Z-0137-2027	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.; 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	18
Z-0138-2027	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.; 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	20

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately discard any Grafton DBM or Grafton Plus DBM products with serial numbers A62881-014 through A62881-033.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

FDA distribution: “US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, Colorado, Delaware, Florida, Georgia, Illinois, Kansas, Maryland, Michigan, Oklahoma, Texas, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 12, 2026Firm started the recall
Oct 9, 2026FDA classified it Class II
Oct 21, 2026Published in FDA’s Enforcement Report
Oct 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/1764901-medtronic-sofamor-danek-usa-inc-recalls-grafton-dbm-and-grafton">Grafton DBM and Grafton Plus DBM Recall: Risk of Clostridium Infection (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0138-2027 (August 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0138-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.