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GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) recallZ-0138-2027 · Medtronic Sofamor Danek USA Inc · initiated Aug 12, 2026

Open, Classified All recalls posted in October 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

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]

Recall details

Recall number
Z-0138-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Aug 12, 2026
Posted by the FDA
Oct 9, 2026
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
20
Product code
MBP
FDA submissions
K051188, K051195
Distribution
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

31 devices cleared under K051188, K051195 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99701).

Sources and updates

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