Date Initiated by Firm |
December 03, 2009 |
Date Posted |
January 13, 2010 |
Recall Status1 |
Terminated 3 on May 05, 2010 |
Recall Number |
Z-0622-2010 |
Recall Event ID |
53981 |
510(K)Number |
K932425
|
Product Classification |
Knee Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
|
Product |
Foundation 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 |
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 |
Action |
Firm 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 Commerce |
17 |
Distribution |
Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey. |
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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