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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
K932425 
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/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Consumer Instructions Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
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
PRODUCTION CONTROLS: 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 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.
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