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U.S. Department of Health and Human Services

Class 3 Device Recall DePuy Orthopedics

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  Class 3 Device Recall DePuy Orthopedics see related information
Date Initiated by Firm December 22, 2003
Date Posted August 24, 2004
Recall Status1 Terminated 3 on September 23, 2004
Recall Number Z-1369-04
Recall Event ID 29314
510(K)Number K952830  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product P.F.C. ¿ ¿ Knee System 7¿
Fluted Femoral Stem 18mmX125mm
REF 96-1703
Code Information Lot Number: 226436R
Recalling Firm/
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Rick Sedlatschek
Manufacturer Reason
for Recall
The collar was incorrectly etched for the R (right) and L (Left) orientation
FDA Determined
Cause 2
Action Depuy notified distributors at the various territories via verbal contact on 12/23/2003
Quantity in Commerce 1 unit
Distribution NY
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 PROFESSIONALS, INC.