BEUDAMED
    FDA Enforcement Class II Terminated

    OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101

    Recall: Z-1896-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1896-2021
    Event ID
    88075
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 23, 2021
    Initiation Date
    June 1, 2021
    Classification Date
    June 17, 2021
    Termination Date
    June 22, 2023
    Address
    27051 Towne Centre Dr, Foothill Ranch, CA, 92610-2804, United States

    Description

    OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101

    Reason

    Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.

    Code Info

    REF Number: MJS-101; MJSR-101. Lot Numbers: MX180425 through MX200306

    Distribution

    U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Not provided.

    Quantity

    10,469 items