Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall DePuy Orthopedics

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall DePuy Orthopedics see related information
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
-
-