Recall Z-0467-03 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics
Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
| Date | Jan 28, 2003 (initiated Dec 2, 2002) |
| Status | Terminated |
| Reason | Product mix-up. 16mm stem in a 18mm package. |
| Root cause | Other |
| Action | Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors. |
| Quantity | 6 |
| Distribution | The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944836 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp., Apr 10, 1995 |