BEUDAMED
    FDA Recall Open, Classified

    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

    Recall: Z-1216-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1216-2022
    Event Number
    90052
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    LXH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 3, 2022
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    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.

    Action

    The recalling firm issued recall notification letters on May 3, 2022 via UPS ground. Consignees are asked to do the following: 1. Immediately cease sterilizing the kitted Aequalis" Perform" Reversed Ratcheting Screwdriver Handle (MWJ128) in an Aesculap container. a. If sterilization in an Aesculap container is desired, the handle (MWJ128) shall be removed from the kit (YKAD261) prior to sterilization and then sterilized separately. To ensure sterility, the handle (MWJ128) must be double-wrapped and sterilized individually according to the parameters provided in the table below and provided within the new Instructions for Use online at https://ifu.stryker.com/. b. If the kit, YKAD261, contains the previous version (IFU 7638), discard the previous IFU and reference the eIFU (IFU 017) for instructions. 2. Disseminate this notice to all those who need to be aware within your organization. 3. Return the enclosed business reply form by email to confirm receipt of this notification. 4. Inform Stryker if any of the subject devices have been distributed to other organizations.

    Distribution

    US Nationwide distribution.

    Quantity

    1066 units