BEUDAMED
    FDA Enforcement Class II Terminated

    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    Recall: Z-1512-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1512-2021
    Event ID
    87727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DJ Orthopedics de Mexico S.A. de C.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 5, 2021
    Initiation Date
    April 12, 2021
    Classification Date
    April 29, 2021
    Termination Date
    March 21, 2024
    Address
    Carretera Libre Tijuana-Tecate, 20230 Submetropoli El Florido, Tijuana, N/A, N/A, Mexico

    Description

    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    Reason

    failed rivet at the chafe tab of arm sling.

    Code Info

    Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

    Quantity

    N/A