BEUDAMED
    FDA Recall Terminated

    Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-12 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

    Recall: Z-2744-2011 · Initiated May 20, 2011

    Recall

    Recall Number
    Z-2744-2011
    Event Number
    58919
    Firm
    Cambridge Endoscopic Devices, Incorporated
    FEI Number
    3005256487
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 20, 2011
    Posted
    July 6, 2011
    Terminated
    July 24, 2012
    Address
    119 Herbert Street, Framingham, MA, 01702-8774

    Description

    Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-12 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

    Reason

    PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors

    Action

    Cambridge Endoscopic Devices, Inc. sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced. Questions regarding this recall, call 508-405-0790 for assistance.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Armenia , Australia, Austria, Chile, China, Denmark, Hong Kong, India, Ireland , Italy, Japan, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

    Quantity

    255 units