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.
FDA Recall Z-0908-2018 · Posted None
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2017-09-15
Date Terminated2018-12-19
Product Quantity163
Reason for Recall
The device cartridge disengaged during use due to manufacturing error.
Firm Action
Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: [email protected]. For further questions, please call (203) 492-5000.
Root Cause
Process control
Distribution Pattern
Internationally, including Japan. No USA Customers
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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