Device recall
Z-1009-2015: The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1009-2015 |
|---|---|
| Recall event | 69533 |
| Product | The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to… |
| Product code | MQN |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2016 |
| 510(k) numbers | K040169, K050378 |
| FEI number | 3005180112 |
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