BEUDAMED
    FDA Enforcement Class II Terminated

    TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    Recall: Z-2321-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2321-2016
    Event ID
    74548
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    June 27, 2016
    Classification Date
    August 2, 2016
    Termination Date
    May 30, 2017
    Address
    Sulzer Allee 8, Winterthur, N/A, Switzerland

    Description

    TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    Reason

    Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

    Code Info

    Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12

    Distribution

    Domestic: CO, IL Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay

    Quantity

    169