Grafton Dbm

• • Ongoing Z-0138-2027 FDA Not yet classified ·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.

510(k) Number

K051188 ↗

FDA Product Code

NUN

Device Class

Class II

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

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. →