Recall Z-1163-2010 ยท KOG
Olympus America Inc.
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 and therapeutic tools through the abdominal wall.
| Date | Mar 18, 2010 (initiated Feb 8, 2010) |
| Status | Terminated |
| Reason | weak weld seams |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product. |
| Quantity | 45 |
| Distribution | Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada |
| FDA record | Open on fda.gov |