Z-0137-2027Class II

Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to...

Name: Z-0137-2027 Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2026-08-12
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-0137-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-10-09
Recalling firm: Medtronic Sofamor Danek USA Inc
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.
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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
FDA root cause: Process change control
Action: On 8/12/2026, recall notices were mailed or emailed to customers who were asked to do the following: 1) Identify and quarantine any unused impacted product(s). 2) Return affected product(s) per the return instructions in the enclosed Customer Confirmation Form. If product was purchased directly from Medtronic please contact: [email protected], 3) For patients already implanted with affected products, consider potential Clostridium infection if the patient presents with signs or symptoms of infection. If a patient develops an infection with clostridium at a remote site, evaluate the surgical site for potential infection. 4) Share this Field Safety Notice with all individuals within your organization who need to be aware of this action. If any impacted products have been transferred to another organization, please ensure that a copy of this notice is provided to that organization as well. 5) Complete and return the Customer Confirmation Form via email to [email protected]
Quantity in commerce: 18
Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-09
Z-0138-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-09

Product code MBP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)