FDA Recall
Terminated
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.
Recall: Z-1163-2010
·
Initiated February 8, 2010
Recall
- Recall Number
- Z-1163-2010
- Event Number
- 54634
- Firm
- Olympus America Inc.
- FEI Number
- 2429304
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 8, 2010
- Posted
- March 18, 2010
- Terminated
- May 25, 2010
- Address
- 3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610
Description
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.
Reason
weak weld seams
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.
Distribution
Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada
Quantity
45