Device recall
Z-0941-2013: Large Combination Clamp/Large External Fixation System, Part Number 390.005…
FDA device recall · Class II · Synthes USA HQ, Inc.
Key facts
| Recall number (Z-number) | Z-0941-2013 |
|---|---|
| Recall event | 64159 |
| Product | Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. |
| Product code | KTT |
| Recalling firm | Synthes USA HQ, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2015 |
| 510(k) numbers | K082650 |
| 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