Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall Z-0467-2008 · Posted 2007-12-14
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2007-09-28
Date Terminated2008-10-27
Product Quantity123
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.