FDA-Device2013-06-05Class II

NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.

Zimmer, Inc.
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.

Sold states
Nationwide Distribution.
Affected count
69 units
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2013

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