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GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) A42308

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K051188; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994985910 UDI-DI Date20 Jul 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

14 recalls · 1 ongoing · FDA

    • Ongoing Z-0138-2027 FDA Class II initiated 12 Aug 2026 on shared 510(k) K051188

    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.

    • Terminated Z-0977-2014 FDA Class II initiated 6 Jan 2014 on shared 510(k) K051188

    Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.

  • 12 recalls, same reason

    • Terminated Z-0088-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0091-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0085-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0086-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0094-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0087-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0084-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0090-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0089-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0093-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0092-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188
    • Terminated Z-0083-2013 FDA Class II initiated 20 Apr 2012 on shared 510(k) K051188

    Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Generic Name
Human-derived demineralized bone matrix implant
Model / Reference
A42308
Primary DI / UDI-DI
00613994985910
510(k) Number
FDA Product Code
NUN
GMDN Term
Human-derived demineralized bone matrix implant
Device Class
Class II
Regulation Number
872.3930
GUDID distribution status
Not in Commercial Distribution
Size
Length — 10.0 Millimeter
Width — 8.0 Millimeter

Related devices

Cleared under the same submission (K051188)

Show all (12)

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • HCT/P
  • Lot / Batch Number

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No