CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Grafton" DBM and Grafton Plus" DBM contain demineralized recalled

Medtronic Sofamor Danek USA is recalling Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with, distributed nationwide in the US. The recall was initiated on 12 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled18

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0137-2027
FDA event ID: 99701
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 12 Aug 2026
FDA classified: 9 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Reason category: Other Bacterial Contamination
Device type: Hip & Knee Implants

Timeline

12 Aug 2026	Recall initiated by company
9 Oct 2026	Classified by FDA	+58 days
21 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.

Nationwide Alabama Arkansas Colorado Delaware Florida Georgia Illinois Kansas Maryland Michigan Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99701

This product is part of a recall event; the main page for the event is Grafton" DBM and Grafton Plus" DBM contain demineralized recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	Grafton" DBM and Grafton Plus" DBM contain demineralized recalled	Medtronic Sofamor Danek USA	Other Bacterial Contamination	Nationwide

More recalls from Medtronic Sofamor Danek USA

All 79

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Grafton" DBM and Grafton Plus" DBM contain demineralized recalled	Medtronic Sofamor Danek USA	Other Bacterial Contamination	Nationwide
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Putty recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN

Other Hip & Knee Implants recalls

All 3,115

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	Grafton" DBM and Grafton Plus" DBM contain demineralized recalled	Medtronic Sofamor Danek USA	Other Bacterial Contamination	Nationwide
21 Oct 2026Device	CLASS II	Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
14 Oct 2026Device	CLASS II	Intellijoint Navigation System: Workstation G2 Configured recalled	Intellijoint Surgical	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide