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U.S. Department of Health and Human Services

Class 2 Device Recall Impactor

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  Class 2 Device Recall Impactor see related information
Date Initiated by Firm August 04, 2008
Date Posted September 29, 2008
Recall Status1 Terminated 3 on August 03, 2009
Recall Number Z-2466-2008
Recall Event ID 49116
510(K)Number k923277  k941306  k960008  k970031  
Product Classification Prosthesis, knee - Product Code JWH
Product FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.
Code Information All Revision A and Revision B Impactors.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
FDA Determined
Cause 2		 Device Design
Action Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.
Quantity in Commerce 68 units.
Distribution FL and TX and OUS: 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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
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