FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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
- Recall number
- Z-0465-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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
- Status
- Terminated
- Initiated
- 2007-09-28
- Posted
- 2007-12-14
- Terminated
- 2008-10-27
- Reason
- Mis-labeling; The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
- 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
- 122
- Distribution
- Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
- Lot, serial or model codes
- Lot Numbers: G1478920, G1478921, G1540970, G1560385, G1576129, G1576131, G1589768, G1589769, and G1589770
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28