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GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) A43102

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

15 ongoing

This device is named in the recall

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 Number00613994985897 UDI-DI Date20 Jul 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

30 recalls · 15 ongoing · FDA

    • Ongoing Z-0138-2027 FDA Class II initiated 12 Aug 2026

    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.

  • 7 recalls, same reason

    • Ongoing Z-0162-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0163-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0166-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0165-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0164-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0167-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0161-2024 FDA Class II initiated 26 Sep 2023

    Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

  • 7 recalls, same reason

    • Ongoing Z-1325-2023 FDA Class II initiated 8 Feb 2023
    • Ongoing Z-1323-2023 FDA Class II initiated 8 Feb 2023
    • Ongoing Z-1326-2023 FDA Class II initiated 8 Feb 2023
    • Ongoing Z-1333-2023 FDA Class II initiated 8 Feb 2023
    • Ongoing Z-1328-2023 FDA Class II initiated 8 Feb 2023
    • Ongoing Z-1324-2023 FDA Class II initiated 8 Feb 2023
    • Ongoing Z-1327-2023 FDA Class II initiated 8 Feb 2023

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    • Terminated Z-0977-2014 FDA Class II initiated 6 Jan 2014

    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-0084-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0087-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0083-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0088-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0091-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0085-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0086-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0094-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0092-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0090-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0089-2013 FDA Class II initiated 20 Apr 2012
    • Terminated Z-0093-2013 FDA Class II initiated 20 Apr 2012

    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.

  • 2 recalls, same reason

    • Terminated Z-0415-2012 FDA Unclassified (pre-2012) initiated 8 Aug 2011
    • Terminated Z-0416-2012 FDA Unclassified (pre-2012) initiated 8 Aug 2011

    Aseptic conditions during the production of these products may have been compromised.

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
A43102
Primary DI / UDI-DI
00613994985897
510(k) Number
FDA Product Code
MBP, MQV
GMDN Term
Human-derived demineralized bone matrix implant
Device Class
Class II
Regulation Number
888.3045
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K051195)

Show all (12)

Other devices from Medtronic Sofamor Danek, Inc.

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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