Z-1376-2013 Class II Terminated
FDA device recall Z-1376-2013 was initiated by Zimmer, Inc. on Mar 27, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 26, 2017). Affected quantity: 69 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 5, 2013
- Initiation Date
- Mar 27, 2013
- Termination Date
- Jan 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69 units
Product Description
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Part No. 00-5887-052-00; lots 62181290 and 62183430
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1376-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026