Grafton Dbm

• • Ongoing Z-0138-2027 FDA Not yet classified ·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-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-0161-2024 FDA Class II ·initiated 26 Sep 2023
  • Ongoing Z-0162-2024 FDA Class II ·initiated 26 Sep 2023
  • Ongoing Z-0167-2024 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.

510(k) Number

K051195 ↗

FDA Product Code

MBP

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Alloprep System

  Class I

  FDA 510(k) K883065 Active Cleared 13 Oct 1988

• Graftcage Tlx

  Class II

  FDA 510(k) K051781 Active Cleared 16 Dec 2005

• Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices Open recall

  Class II

  FDA 510(k) K082615 Active Cleared 16 Oct 2008

• Grafton Plus Dbm Paste Open recall

  Class II

  FDA 510(k) K042707 Active Cleared 30 Nov 2005

• Plexur M

  Class II

  FDA 510(k) K073405 Active Cleared 3 Mar 2008

• Osteotech Musculoskeletal Tissue Recovery Pack

  Class I

  FDA 510(k) K951811 Active Cleared 31 May 1995

See all devices from Osteotech, Inc. →