Grafton Plus Dbm Paste

• • Ongoing Z-0137-2027 FDA Not yet classified ·initiated 12 Aug 2026 ·on shared 510(k) K042707

  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

• 12 recalls, same reason

  • Terminated Z-0083-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0088-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0091-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0085-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0086-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0087-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0092-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0084-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0090-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0089-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0093-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707
  • Terminated Z-0094-2013 FDA Class II ·initiated 20 Apr 2012 ·on shared 510(k) K042707

  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

K042707 ↗

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

• 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

• Graftcage Acx

  Class II

  FDA 510(k) K053080 Active Cleared 1 Dec 2005

See all devices from Osteotech, Inc. →