Z-0463-2008

Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT...

Name: Z-0463-2008 Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-09-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-09-28 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2007-09-28. The reason FDA records is "Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0463-2008
Status: Terminated
Initiated: 2007-09-28
Posted: 2007-12-14
Terminated: 2008-10-27
Recalling firm: Howmedica Osteonics Corp
Product: 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
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: packaging
FDA root 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: 59
Distribution: Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
Product codes and lots: Lot Numbers: G1312594, G1478915, G1478917, G1565961, and G1589683

Product code LPH

K063822Class IIModification to Hipstar Femoral StemStryker Orthopaedics / cleared 2007-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)