Device recall
Z-0111-2010: Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number…
FDA device recall · Class I · Synthes USA (HQ), Inc.
Key facts
| Recall number (Z-number) | Z-0111-2010 |
|---|---|
| Recall event | 53509 |
| Product | Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. |
| Product code | MQP |
| Recalling firm | Synthes USA (HQ), Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 9, 2015 |
| 510(k) numbers | K003836 |
| FEI number | 3005180112 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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