Device recall
Z-1163-2010: Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and…
FDA device recall · Class II · Olympus America Inc.
Key facts
| Recall number (Z-number) | Z-1163-2010 |
|---|---|
| Recall event | 54634 |
| Product | Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic… |
| Product code | KOG |
| Recalling firm | Olympus America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2010 |
| 510(k) numbers | K790071, K923982 |
| FEI number | 2429304 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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