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Terminated

Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

FDA Recall Z-0463-2008 · Posted 2007-12-14

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2007-09-28
Date Terminated2008-10-27
Product Quantity59

Reason for Recall

Mis-labeled: 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063822MODIFICATION TO HIPSTAR FEMORAL STEMStryker Orthopaedics · 2007-01-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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