Device recall
Z-1029-2015: Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert…
FDA device recall · Class II · Orthosensor, Inc.
Key facts
| Recall number (Z-number) | Z-1029-2015 |
|---|---|
| Recall event | 69963 |
| Product | Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery. |
| Product code | ONN |
| Recalling firm | Orthosensor, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2015 |
| 510(k) numbers | K130380 |
| FEI number | 3008592715 |
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