Device recall
Z-0341-2018: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF…
FDA device recall · Class II · SPINEART SA
Key facts
| Recall number (Z-number) | Z-0341-2018 |
|---|---|
| Recall event | 78640 |
| Product | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with… |
| Product code | KWQ |
| Recalling firm | SPINEART SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2019 |
| 510(k) numbers | K153042 |
| FEI number | 3007728266 |
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