Device recall
Z-0909-2015: Cypher MIS Screw System-The system includes screws, various types and sizes of…
FDA device recall · Class II · Ebi, Llc
Key facts
| Recall number (Z-number) | Z-0909-2015 |
|---|---|
| Recall event | 69785 |
| Product | Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct… |
| Product code | NKB |
| Recalling firm | Ebi, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2015 |
| 510(k) numbers | K123549 |
| FEI number | 2242816 |
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