Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rota
FDA device recall Z-1037-2012 · posted 2012-02-15 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc.
- Reason for recall
- The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
- Action taken
- Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- max
- Quantity affected
- 52
- Distribution
- Nationwide and Puerto Rico
- Date initiated
- 2012-02-06
- Date posted
- 2012-02-15
- Date terminated
- 2012-06-11
- Location
- Lewisville, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FORZA SPACER SYSTEM (K103111) | Orthofix, Inc. | 2011-03-23 |