BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

    Recall: Z-1477-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1477-2024
    Event ID
    94194
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 10, 2024
    Initiation Date
    March 6, 2024
    Classification Date
    April 4, 2024
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423, United States

    Description

    stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

    Reason

    Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

    Code Info

    UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094

    Distribution

    US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK

    Quantity

    47 units