Class 2 Device Recall Trabecular Metal" Tibia Stop Drill

• Date Initiated by Firm: March 27, 2013
• Date Posted: May 24, 2013
• Recall Status: Terminated on January 26, 2017
• Recall Number: Z-1376-2013
• Recall Event ID: 65042
• 510(K)Number: K012866 K020295
• Product Classification: Bit, drill - Product Code HTW
• Product: NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
• Code Information: Part No. 00-5887-052-00; lots 62181290 and 62183430
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Zimmer Customer Call Center; 800-447-5633
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 69 units
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HTW