Device recall
Z-0973-2015: Malleable C- Retractor, Part Number 397.232, used to provide retraction of the…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-0973-2015 |
|---|---|
| Recall event | 70018 |
| Product | Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System… |
| Product code | GAD |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2016 |
| FEI number | 3005180112 |
At a glance
- None 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