FDAClass IIJune 5, 2013

NEXGEN Complete Knee Solution Monoblock Tibial Drill recall

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

Why was NEXGEN Complete Knee Solution Monoblock Tibial Drill recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part No. 00-5887-052-00; lots 62181290 and 62183430

Product
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Recalling firm
Zimmer, Inc.
Quantity
69 units
Distribution
Nationwide Distribution.
Recall date
June 5, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls