The Nexgen Tmt Tibia, Models 00-5886-Xxyy, 05-120-Xxyy-0

• • Terminated Z-1376-2013 FDA Class II ·initiated 27 Mar 2013 ·on shared 510(k) K012866

  Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.

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

510(k) Number

K012866 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K031449 Active Cleared 23 Sep 2003

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  Class II

  FDA 510(k) K971789 Active Cleared 24 Jul 1997

• Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 System

  Class II

  FDA 510(k) K980486 Active Cleared 14 Apr 1998

See all devices from Implex Corp. →