Device recall
Z-1037-2012: Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer…
FDA device recall · Class II · Orthofix, Inc.
Key facts
| Recall number (Z-number) | Z-1037-2012 |
|---|---|
| Recall event | 61117 |
| Product | Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium. |
| Product code | max |
| Recalling firm | Orthofix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2012 |
| 510(k) numbers | K103111 |
| FEI number | 2183449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database