Z-0908-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- September 15, 2017
- Termination Date
- December 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163
Product Description
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Reason for Recall
The device cartridge disengaged during use due to manufacturing error.
Distribution Pattern
Internationally, including Japan. No USA Customers
Code Information
Product number: EGIARADXT Lot code: N6L0351X