BEUDAMED
    FDA Enforcement Class II Ongoing

    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

    Recall: Z-1216-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1216-2022
    Event ID
    90052
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    May 3, 2022
    Classification Date
    June 1, 2022
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    Description

    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

    Reason

    The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

    Code Info

    Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes

    Distribution

    US Nationwide distribution.

    Quantity

    1066 units