Recall Z-1376-2013 ยท HTW Bit, Drill
Zimmer, Inc.
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
| Date | May 24, 2013 (initiated Mar 27, 2013) |
| Status | Terminated |
| Reason | Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide. |
| Root cause | Process control |
| Action | Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. |
| Quantity | 69 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |