Device recall
Z-1609-2016: TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do…
FDA device recall · Class II · Applied Medical Technology Inc
Key facts
| Recall number (Z-number) | Z-1609-2016 |
|---|---|
| Recall event | 73318 |
| Product | TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure. |
| Product code | GAD |
| Recalling firm | Applied Medical Technology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2016 |
| FEI number | 1526012 |
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