Recall Z-0349-03 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Howmedica Osteonics Corp
Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
| Date | Dec 19, 2002 (initiated Nov 12, 2002) |
| Status | Terminated |
| Reason | Hip Stem Fractures in the neck area. |
| Root cause | Other |
| Action | Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002. |
| Quantity | 16 |
| Distribution | Product was distributed to hospitals and Howmedica Branch reps throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993768 | CITATION TMZF HA STEM Howmedica Osteonics Corp., Jan 21, 2000 |