Tc-Plus Solution Knee

• 7 recalls, same reason

  • Terminated Z-0016-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005
  • Terminated Z-0019-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005
  • Terminated Z-0014-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005
  • Terminated Z-0015-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005
  • Terminated Z-0013-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005
  • Terminated Z-0018-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005
  • Terminated Z-0017-06 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005

  Did not meet specifications.

• • Terminated Z-0126-06 FDA Unclassified (pre-2012) ·initiated 22 Feb 2005

  Labeling discrepancy.

• • Terminated Z-0017-04 FDA Unclassified (pre-2012) ·initiated 17 Apr 2003 ·on shared 510(k) K000666

  Labeling/packaging mix-up.

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

510(k) Number

K000666 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

See all devices from Plus Orthopedics →