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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Baseplate

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 Class 2 Device Recall Foundation Baseplatesee related information
Date Initiated by FirmDecember 03, 2009
Date PostedJanuary 13, 2010
Recall Status1 Terminated 3 on May 05, 2010
Recall NumberZ-0622-2010
Recall Event ID 53981
510(K)NumberK932425 
Product Classification Knee Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
ProductFoundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.
Code Information Lot number 53986069
FEI Number 1000116912
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionFirm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275.
Quantity in Commerce17
DistributionWorldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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