—#117771

Product

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

FDA product code: HTW — Bit, Drill
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K012866, K020295
Affected lot / code info: Part No. 00-5887-052-00; lots 62181290 and 62183430

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-03-27
Posted by FDA: 2013-05-24
Terminated: 2017-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117771. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.