FDANovember 20, 2017device

Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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