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Class 2 Device Recall |
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Date Initiated by Firm |
June 07, 2005 |
Date Posted |
July 21, 2005 |
Recall Status1 |
Terminated 3 on May 02, 2006 |
Recall Number |
Z-1026-05 |
Recall Event ID |
32282 |
PMA Number |
P830055/R44 |
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
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Product |
Depuy brand LCS Complete metal backed patella, porocoat, LRG; REF 1294-09-660. |
Code Information |
Lots 1829092, 1831726, 1837370, 1845654, 1848385 and 1855839. |
Recalling Firm/ Manufacturer |
Depuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
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For Additional Information Contact |
800-366-8143
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Manufacturer Reason for Recall |
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
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FDA Determined Cause 2 |
Other |
Action |
Hospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm. |
Distribution |
Nationwide and international. |
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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PMA Database |
PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.
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