BEUDAMED
    FDA Recall Terminated

    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 · Initiated May 1, 2013

    Recall

    Recall Number
    Z-1521-2013
    Event Number
    65217
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa
    FEI Number
    2027111
    Product Code
    NWV
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 1, 2013
    Posted
    June 7, 2013
    Terminated
    February 6, 2014
    Address
    Margarita, CA, 92688-2650

    Description

    Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    Reason

    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;

    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.

    Distribution

    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.

    Quantity

    127,305 units