FDAFDA · Food and drugs·Recall number Z-1376-2013
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Published June 5, 2013 · Recall initiated: March 27, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- Part No. 00-5887-052-00; lots 62181290 and 62183430
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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