FDAFDA · Food and drugs·Recall number Z-0851-2015
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
Published December 31, 2014 · Recall initiated: December 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Distributor
- Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
- Lot
- Part number 00-5887-045-00 Lot number 62592928
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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