BEUDAMED
    FDA Enforcement Class II Terminated

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    Recall: Z-2408-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2408-2018
    Event ID
    80131
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    April 27, 2018
    Classification Date
    July 10, 2018
    Termination Date
    May 21, 2020
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    Reason

    The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

    Code Info

    GTIN: 04546540673428; Lot code: K081639

    Distribution

    The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.