Recall Z-0851-2015— Zimmer Trabecular Metal Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Trabecular Metal Technology, Inc., initiated 2014-12-02, terminated 2015-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle..
- Recalling firm
- Zimmer Trabecular Metal Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-02
- Terminated
- 2015-08-28
- Firm location
- Parsippany, NJ, United States
Product 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 for recall
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.