Device product
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Z-1376-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 65042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69 units
- Official record key
device-enforcement:Z-1376-2013
Official wording
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.
Code information: Part No. 00-5887-052-00; lots 62181290 and 62183430
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.