Device recall
Z-0239-2018: Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha…
FDA device recall · Class II · Amendia, Inc dba Spinal Elements
Key facts
| Recall number (Z-number) | Z-0239-2018 |
|---|---|
| Recall event | 78592 |
| Product | Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended… |
| Product code | KWQ |
| Recalling firm | Amendia, Inc dba Spinal Elements |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2019 |
| 510(k) numbers | K092531 |
| FEI number | 3007970248 |
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