| Class 2 Device Recall Hipstar V40 Femoral Stem | |
Date Initiated by Firm | September 28, 2007 |
Date Posted | December 14, 2007 |
Recall Status1 |
Terminated 3 on October 27, 2008 |
Recall Number | Z-0468-2008 |
Recall Event ID |
45334 |
Product Classification |
Femoral Stem - Product Code LPH
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Product | Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair |
Code Information |
Lot Numbers: G1313059, G1479784, G1479785, G1540973, G1579465, G1579466, G1620890, G1620891, G1632578, and G1709769 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
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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 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 | 105 |
Distribution | Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA |
Total Product Life Cycle | TPLC Device Report |
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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.
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