Device recall
Z-1835-2015: Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73…
FDA device recall · Class II · Stryker Sustainability Solutions
Key facts
| Recall number (Z-number) | Z-1835-2015 |
|---|---|
| Recall event | 71394 |
| Product | Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures. |
| Product code | NLM |
| Recalling firm | Stryker Sustainability Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2016 |
| 510(k) numbers | K063788 |
| FEI number | 3009350690 |
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