FDA-Device2014-12-31Class II
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
Zimmer Trabecular Metal Technology, Inc.
Hazard
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Sold states
Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
Affected count
8 units
Manufactured in
10 Pomeroy Rd, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0851-2015Don't want to check this manually?
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