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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 Orthopedicssee related information
Date Initiated by FirmJanuary 15, 2004
Date PostedAugust 24, 2004
Recall Status1 Terminated 3 on September 23, 2004
Recall NumberZ-1382-04
Recall Event ID 29309
510(K)NumberK923807 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
ProductP.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 ContactRick Sedlatschek
574-372-7322
Manufacturer Reason
for Recall
Screw size included in system was incorrect
FDA Determined
Cause 2
Other
ActionDePuy notified the sales territories via verbal contact with the distributors on 1/15/04.
Quantity in Commerce1 unit
DistributionIA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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