FDA Enforcement
Class II
Terminated
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
Recall: Z-0851-2015
·
Reported December 31, 2014
Enforcement
- Recall Number
- Z-0851-2015
- Event ID
- 69866
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Trabecular Metal Technology, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- December 2, 2014
- Classification Date
- December 23, 2014
- Termination Date
- August 28, 2015
- Address
- 10 Pomeroy Rd, Parsippany, NJ, 07054-3722, United States
Description
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
Reason
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Code Info
Part number 00-5887-045-00 Lot number 62592928
Distribution
Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
Quantity
8 units