Device recall
Z-2677-2014: Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the…
FDA device recall · Class II · Genesys Orthopedics Systems, LLC
Key facts
| Recall number (Z-number) | Z-2677-2014 |
|---|---|
| Recall event | 67900 |
| Product | Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment… |
| Product code | NKB |
| Recalling firm | Genesys Orthopedics Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2015 |
| 510(k) numbers | K100757 |
| FEI number | 3008455034 |
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