Recall Z-0851-2015 ยท HXB Probe
Zimmer Trabecular Metal Technology, Inc.
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
| Date | Dec 23, 2014 (initiated Dec 2, 2014) |
| Status | Terminated |
| Reason | During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle. |
| Root cause | Device Design |
| Action | Zimmer, Inc. sent recall letters/ hospital risk managers emails and letters via courier service on December 2, 2014. Inventory Return Certification Forms were also provided. Your responsibilities are: 1. Locate all products from the identified lot above and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1), and email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Inventory Return Certificati |
| Quantity | 8 units |
| Distribution | Worldwide Distribution - US Distribution and the countries of Australia and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.