BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S

    Recall: Z-2884-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2884-2018
    Event ID
    80613
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    June 27, 2018
    Classification Date
    August 22, 2018
    Termination Date
    April 13, 2020
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S

    Reason

    Incomplete seal on the Tyvek lid may compromise the sterility of the device

    Code Info

    Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C

    Distribution

    US distribution to KY

    Quantity

    38