Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle component
FDA device recall Z-0587-03 · posted 2003-02-27 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- Some components have disassociated post-operatively resulting in additional surgery to the patient.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 136
- Distribution
- The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
- Date initiated
- 2003-01-07
- Date posted
- 2003-02-27
- Date terminated
- 2003-07-31
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM (K952970) | Howmedica Corp. | 1996-01-17 |