BEUDAMED
    FDA Enforcement Class II Terminated

    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223

    Recall: Z-3204-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3204-2017
    Event ID
    77911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2017
    Initiation Date
    July 10, 2017
    Classification Date
    September 22, 2017
    Termination Date
    August 5, 2019
    Address
    1900 Aston Ave, N/A, Carlsbad, CA, 92008-7308, United States

    Description

    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223

    Reason

    Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

    Code Info

    lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028

    Distribution

    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)

    Quantity

    349 products