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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 19, 2003
Date Posted January 14, 2004
Recall Status1 Terminated 3 on March 03, 2005
Recall Number Z-0339-04
Recall Event ID 27848
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented - Product Code LWJ
Product Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
Code Information Catalog numbers, 11911, 11912, 11913, 11914, 11930, 11931
Recalling Firm/
Plus Orthopedics
6055 Lusk Blvd
San Diego CA 92121
For Additional Information Contact Neil Delaney
Manufacturer Reason
for Recall
Design Change
FDA Determined
Cause 2
Action Notify all implanting physicians of the removal and weight restrictions, and to evaluate thier patients for adherence to the weight restriction.
Quantity in Commerce 53
Distribution CA, AZ, NV, NV, CO
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.