Depuy Sigma Tibial Inserts and Co-Cr Tibial Trays

• 12 recalls, same reason

  • Terminated Z-0412-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0417-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0416-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0414-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0413-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0420-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0422-2014 FDA Class II ·initiated 18 Nov 2013 ·on shared 510(k) K032151
  • Terminated Z-0421-2014 FDA Class II ·initiated 18 Nov 2013 ·on shared 510(k) K032151
  • Terminated Z-0419-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0415-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0423-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0418-2014 FDA Class II ·initiated 18 Nov 2013

  DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

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

510(k) Number

K032151 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

  Class II

  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →