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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Knee Revision Baseplate

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  Class 2 Device Recall Foundation Knee Revision Baseplate see related information
Date Initiated by Firm December 11, 2009
Date Posted February 24, 2010
Recall Status1 Terminated 3 on September 24, 2010
Recall Number Z-0826-2010
Recall Event ID 54197
510(K)Number K932425  
Product Classification Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis - Product Code JWH
Product Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
Code Information Lot 53944312
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.
FDA Determined
Cause 2		 Process control
Action Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.
Quantity in Commerce 17
Distribution TX, FL, GA, CA, AZ, 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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