Date Initiated by Firm |
January 15, 2004 |
Date Posted |
August 24, 2004 |
Recall Status1 |
Terminated 3 on September 23, 2004 |
Recall Number |
Z-1382-04 |
Recall Event ID |
29309 |
510(K)Number |
K923807
|
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
Product |
P.F.C.¿ Modular Knee System Modular Plus Tibial Wedge 10¿ HEMI x 8.5MM HEIGHT Product Code: 86-0178 |
Code Information |
Lot Umber: 330722 |
Recalling Firm/ Manufacturer |
Depuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
|
For Additional Information Contact |
Rick Sedlatschek 574-372-7322
|
Manufacturer Reason for Recall |
Screw size included in system was incorrect
|
FDA Determined Cause 2 |
Other |
Action |
DePuy notified the sales territories via verbal contact with the distributors on 1/15/04.
|
Quantity in Commerce |
1 unit |
Distribution |
IA |
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 = JOHNSON & JOHNSON INTERNATIONAL
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