Device recall
Z-1681-2014: Synthes XRL Medium Trial - Central Body, an instrument used as part of the…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1681-2014 |
|---|---|
| Recall event | 68006 |
| Product | Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and… |
| Product code | MQP |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2015 |
| 510(k) numbers | K103320 |
| FEI number | 3005180112 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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