FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Recall number
- Z-0227-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Status
- Terminated
- Initiated
- 2008-08-20
- Posted
- 2008-10-31
- Terminated
- 2009-06-01
- Reason
- The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.
- Root cause
- Labeling mix-ups
- Action
- Recall notification letters were sent by Fed Ex on August 20, 2008 to Stryker branches/agencies and Hospital Risk Management departments. Letters to Branches stated the reason for the recall and the potential hazard. Both letters state that it is recommended that physicians follow patients in a manner that is consistent with a physicians routine standard of care for total hip arthroplasty. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5000 for assistance.
- Quantity
- 77 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Catalog # Lot Code 78501006 G1167520 78501006 G1167521 78501006 G1167521 78501006 G1228787 78501006 G1229912 78501006 G1229912 78501006 G1230461 78501006 G1230461 78501006 G1239108 78501006 G1239108 78501007 G1229913 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501009 G1076126 78501009 G1076126 78501009 G1076126 78501009 G1090547 78501009 G1090547 78501009 G1090547 78501009 G1090547 78501009 G1230631 78501009 G1230631 78501010 G1167526 78501010 G1167526 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1285646 78501010 G1285646 78501011 GC981487 78501011 GC981487 78501011 GC981487 78501011 GC981487 78501011 GC981487 and 78501012 GC966512
- 510(k) numbers
- ["K051223"]
- PMA numbers
- not on file
- Product code
- LZO
- 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