Device recall
Z-1674-2011: BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw…
FDA device recall · Class II · Orthofix Inc
Key facts
| Recall number (Z-number) | Z-1674-2011 |
|---|---|
| Recall event | 57199 |
| Product | BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle… |
| Product code | NKB |
| Recalling firm | Orthofix Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2011 |
| 510(k) numbers | K081684 |
| FEI number | 2183449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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