Device recall
Z-1217-2014: Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-1217-2014 |
|---|---|
| Recall event | 67486 |
| Product | Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)… |
| Product code | MNI |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2014 |
| 510(k) numbers | K110197 |
| FEI number | 1038671 |
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