| Class 3 Device Recall Foundation | |
Date Initiated by Firm | May 10, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on August 09, 2004 |
Recall Number | Z-1010-04 |
Recall Event ID |
29130 |
510(K)Number | K923277 |
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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Product | Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758 |
Code Information |
Catalog number 324-01-106, Lot number 991151 |
Recalling Firm/ Manufacturer |
Encore Medical, LP 9800 Metric Blvd Austin TX 78758
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Manufacturer Reason for Recall | Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE |
FDA Determined Cause 2 | Other |
Action | The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product. |
Quantity in Commerce | 15 |
Distribution | Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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