Recall Z-0227-2009 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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
| Date | Oct 31, 2008 (initiated Aug 20, 2008) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051223 | HIPSTAR FEMORAL STEM Stryker Orthopaedics, May 10, 2006 |