BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

    Recall: Z-1291-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1291-2022
    Event ID
    90216
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    June 2, 2022
    Classification Date
    June 27, 2022
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423, United States

    Description

    Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

    Reason

    The instrument is incorrectly color coded.

    Code Info

    Lot #2039558, GTIN 00889797006552.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.

    Quantity

    35 units