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Class 2 Device Recall 3D Knee Tibial InsertDCM |
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Date Initiated by Firm |
March 19, 2010 |
Date Posted |
April 26, 2010 |
Recall Status1 |
Terminated 3 on July 22, 2010 |
Recall Number |
Z-1433-2010 |
Recall Event ID |
55171 |
510(K)Number |
K020114
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product |
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445.
Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.
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Code Information |
Catalog Number: 392-11-604, Lot Number: 59600085. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
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For Additional Information Contact |
512-832-9500
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Manufacturer Reason for Recall |
Affected product had incorrect color label which is a secondary visual indicator for sizing.
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FDA Determined Cause 2 |
Packaging process control |
Action |
Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm.
For further information, contact Encore Medical, LP at 1-888-838-3668. |
Quantity in Commerce |
7 units |
Distribution |
Worldwide Distribution -- United States (UT, IA) and 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 and Original Applicant = ENCORE ORTHOPEDICS, INC.
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