|
Class 2 Device Recall Foundation Knee System |
|
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
|
|
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.
|
|
|
|