Recall Z-0588-03 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics
Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem
| Date | Feb 27, 2003 (initiated Jan 7, 2003) |
| Status | Terminated |
| Reason | Some components have disassociated post-operatively resulting in additional surgery to the patient. |
| Root cause | Other |
| Action | Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices. |
| Quantity | 311 |
| Distribution | The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952970 | HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM Howmedica Corp., Jan 17, 1996 |