Class 2 Device Recall Hipstar V40 Femoral Stem

• Date Initiated by Firm: September 28, 2007
• Date Posted: December 14, 2007
• Recall Status: Terminated on October 27, 2008
• Recall Number: Z-0465-2008
• 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; Catalog No:7850-5-003, IMPLANT SIZE 3,Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
• Code Information: Lot Numbers: G1478920, G1478921, G1540970, G1560385, G1576129, G1576131, G1589768, G1589769, and G1589770
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: 201-831-5000
• 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: 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: 122
• 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.