Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Recall Z-1521-2013 · Posted 2013-06-07
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Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeNWV
Date Initiated2013-05-01
Date Terminated2014-02-06
Product Quantity127,305 units
Reason for Recall
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;
Firm Action
Applied Medical notified customers of the recall beginning on May 13, 2013. The "URGENT: MEDICAL DEVICE RECALL" letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact the firm at (949) 713-8041.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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