BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

    Recall: Z-2105-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2105-2023
    Event ID
    92460
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2023
    Initiation Date
    June 13, 2023
    Classification Date
    July 6, 2023
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

    Reason

    The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

    Code Info

    Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.

    Distribution

    There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

    Quantity

    106 devices