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U.S. Department of Health and Human Services

Class 2 Device Recall Hipstar V40 Femoral Stem

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  Class 2 Device Recall Hipstar V40 Femoral Stem see related information
Date Initiated by Firm September 28, 2007
Date Posted December 14, 2007
Recall Status1 Terminated 3 on October 27, 2008
Recall Number Z-0471-2008
Recall Event ID 45334
Product Classification Femoral Stem - Product Code LPH
Product Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
Code Information Lot Numbers;  G1514923, G1565696, G1589684, and  G1589685 
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact
Manufacturer Reason
for Recall
Mis-labeling: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
FDA Determined
Cause 2
Packaging process control
Action Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Quantity in Commerce 44
Distribution Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
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.