Trabecular Metal Femoral Cone Augments, Model 03-125-Zzzz

• 2 recalls, same reason

  • Terminated Z-2439-2010 FDA Unclassified (pre-2012) ·initiated 5 Jul 2010
  • Terminated Z-2440-2010 FDA Unclassified (pre-2012) ·initiated 5 Jul 2010

  Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.

510(k) Number

K040630 ↗

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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