Device recall
Z-0040-2018: Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior…
FDA device recall · Class II · Genesys Orthopedics Systems, LLC
Key facts
| Recall number (Z-number) | Z-0040-2018 |
|---|---|
| Recall event | 78181 |
| Product | Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the… |
| Product code | LRZ |
| Recalling firm | Genesys Orthopedics Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2018 |
| 510(k) numbers | K133245 |
| FEI number | 3008455034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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