BEUDAMED
    FDA Recall Open, Classified

    Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    Recall: Z-1366-2022 · Initiated June 14, 2022

    Recall

    Recall Number
    Z-1366-2022
    Event Number
    90399
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    QLR
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 14, 2022
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    Reason

    The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

    Action

    The firm sent an URGENT MEDICAL DEVICE RECALL notice on beginning 06/14/2022 by letter (FedEx). The letter discussed the issue and potential risk, an requested the following actions be taken: "1. Immediately check your internal inventory to locate the product listed on the attached business reply form and remove them from their point of use. 2. Return the enclosed business reply form by email to confirm receipt of this notification/document product segregation. a. Response is required, even if you may not have any physical inventory on site anymore. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations. Including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers. 6. Please inform us of any adverse event and/or report them to the Health/Competent Authorities in accordance with current regulations."

    Distribution

    Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

    Quantity

    231