BEUDAMED
    FDA Recall Terminated

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    Recall: Z-1321-2016 · Initiated March 3, 2016

    Recall

    Recall Number
    Z-1321-2016
    Event Number
    73525
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 3, 2016
    Posted
    April 5, 2016
    Terminated
    May 17, 2017
    Address
    7000 W William Cannon Dr, Bldg 1, Austin, TX, 78735-8509

    Description

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    Reason

    During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.

    Action

    Consignees were notified via letter on 3/3/2016. Consignees were instructed to quarantine the recalled products and complete an Inventory Return Certification Form.

    Distribution

    Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, China, Hong Kong, India, Lebanon, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arabic Emirates, Vietnam, Australia, Japan, New Zealand, Brazil, and Chile.

    Quantity

    26,903 devices