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Class 2 Device Recall Foundation Knee System |
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| Date Initiated by Firm |
April 24, 2003 |
| Date Posted |
July 30, 2003 |
| Recall Status1 |
Terminated 3 on July 29, 2003 |
| Recall Number |
Z-1069-03 |
| Recall Event ID |
26297 |
| 510(K)Number |
K923277
|
| Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
| Product |
Foundation Knee System, non-porous Femur Size 8, Right |
| Code Information |
Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611 |
Recalling Firm/
Manufacturer |
Encore Medical, LP
9800 Metric Blvd
Austin TX 78758
|
Manufacturer Reason
for Recall |
Product container was labeled incorrectly indicating left femur instead of right.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors. |
| Quantity in Commerce |
14 unimplanted units |
| Distribution |
PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia |
| 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 and Original Applicant = ENCORE ORTHOPEDICS, INC.
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