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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 Recall
Foundation Knee Revision Baseplate
see related information
Date Posted February 24, 2010
Recall Status1 Terminated on September 24, 2010
Recall Number Z-0826-2010
Recall Event ID 54197
Premarket Notification
510(K) Number
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
Code Information Lot 53944312
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
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
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.