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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Knee System Instrumentation,Tibial Broach

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  Class 2 Device Recall Foundation Knee System Instrumentation,Tibial Broach see related information
Date Initiated by Firm April 21, 2011
Date Posted July 05, 2011
Recall Status1 Terminated 3 on April 06, 2012
Recall Number Z-2734-2011
Recall Event ID 58678
Product Classification Orthopedic Broach - Product Code HTQ
Product Foundation Knee System Instrumentation, Tibial Broach Assembly.

Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.
Code Information P/N 801-01-013 Lot 37641L01
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact David Harris
512-834-6330
Manufacturer Reason
for Recall		 Strike plate may dislodge from the broach stem handle during impaction of the device.
FDA Determined
Cause 2		 Process control
Action Encore Medical, Lp (d.b.a. DJO Global) sent out a "Urgent Field Safety Notice" dated April 20, 2011 to all affected customers. The firm also e-mailed the consignees as well. The letter described the product, affected lots, reason for recall and provided recommendations including; asking customers contact firm for a replacement, provided a "Field Safety Response Form" to fill out and return. The firm also e-mailed the consignees as well. For additional information please contact the Director of Commercial Logistics at (512) 834-6330 or the International Customer Service at 512 834-6275.
Quantity in Commerce 15 units
Distribution Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan.
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.
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