Graftcage Tlx

• • Terminated Z-1931-2012 FDA Class I ·initiated 22 May 2012 ·on shared 510(k) K051781

  Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.

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

510(k) Number

K051781 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Alloprep System

  Class I

  FDA 510(k) K883065 Active Cleared 13 Oct 1988

• 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

• Graftcage Acx

  Class II

  FDA 510(k) K053080 Active Cleared 1 Dec 2005

See all devices from Osteotech, Inc. →