BEUDAMED
    FDA Enforcement Class II Terminated

    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

    Recall: Z-2685-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2685-2020
    Event ID
    85920
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 29, 2020
    Initiation Date
    June 24, 2020
    Classification Date
    July 22, 2020
    Termination Date
    April 28, 2021
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

    Reason

    A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

    Code Info

    Model: 71655139 Lot: 19BM13592A

    Distribution

    International distribution in the countries of Brazil, Colombia and United Arab Emirates.

    Quantity

    12 units