Product Wiki · Recalls · U.S. FDA — Device Enforcement

Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. — recall Z-1521-2013

U.S. FDA — Device Enforcement · United States · 2013-05-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1521-2013
Date of alert
2013-05-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Applied Medical Resources Corp
Product category
device
Product type
Devices
Reported risk: Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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