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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal" Tibia Stop Drill

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  Class 2 Device Recall Trabecular Metal" Tibia Stop Drill see related information
Date Initiated by Firm March 27, 2013
Date Posted May 24, 2013
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-1376-2013
Recall Event ID 65042
510(K)Number K020295  K012866  
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 2		 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 and Original Applicant = IMPLEX CORP.
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