BEUDAMED
    FDA Enforcement Class II Terminated

    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

    Recall: Z-0380-2022 · Reported December 22, 2021

    Enforcement

    Recall Number
    Z-0380-2022
    Event ID
    89014
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 22, 2021
    Initiation Date
    November 9, 2021
    Classification Date
    December 15, 2021
    Termination Date
    December 18, 2023
    Address
    27051 Towne Centre Dr, Foothill Ranch, CA, 92610-2804, United States

    Description

    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

    Reason

    Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

    Code Info

    Instructions for Use Rev. 3 2018

    Distribution

    US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.