Reported Dec 31, 2014 · Terminated

NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer…

Zimmer Trabecular Metal Technology, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Trabecular Metal Technology, Inc. · 10 Pomeroy Rd · Parsippany, NJ · 07054-3722

Is this the product you have?

  • NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
Lot codes and dates
  • Part number 00-5887-045-00 Lot number 62592928
Amount recalled
8 units

Why it was recalled

During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 28, 2015 · Data as of Sep 19, 6:16 PM UTC

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