Device product
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
Z-0851-2015
Product summary
- Event
- Event 69866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0851-2015
Official wording
Reason: During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Code information: Part number 00-5887-045-00 Lot number 62592928
Distribution pattern: Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
Derived failure modes
-
Unknown
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.