BEUDAMED
    FDA Enforcement Class II Terminated

    Posey Connected Twice-As-Tough Cuffs

    Recall: Z-0194-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0194-2020
    Event ID
    82534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TIDI PRODUCTS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    April 12, 2019
    Classification Date
    October 25, 2019
    Termination Date
    July 22, 2020
    Address
    272 E Deerpath, Lake Forest, IL, 60045-5314, United States

    Description

    Posey Connected Twice-As-Tough Cuffs

    Reason

    Not meeting design specifications.

    Code Info

    Model # 2796 with Lots #'s : 7109T007, 7112T001, 122T083, 7185T008, 7192T034, 7194T051, 7200T090, 7250T051, 7263T007, 7313T054, 7355T062, 7361T073, 8018T059, 8038T045, 8041T035, 8081T066, 8122T001, 8122T088, 8129T006, 8130T065, 8344T055, 8347T174, 8346T075, 9002T023, 9064T123, and 9064T124. Model # 2797 with Lots #'s : 7038T010, 7044T051, 059T038, 7061T050, 7088T028, 7089T002, 7090T054, 7100T047, 7103T054, 7114T090, 7114T091, 7151T004, 7154T006, 7156T124, 7163T046, 7165T087, 7178T035, 7181T003, 7185T014, 7186T103, 7271T210, 7284T006, 7284T105, 7291T094, 7317T014, 7340T102, 7347T110, 7354T115, 8004T054, 8024T013, 8025T071, 8047T033, 8055T001, 8071T003, 8096T004, 8106T002, 8113T040, 8115T078, 8117T039, 8178T135, 8183T060, 8249T077, 8261T064, 8263T079, 8270T075, 8278T008, 8281T061, 8284T083, 8304T004, 8305T073, 8312T067, 8320T069, 8330T023, 8331T122, 9007T056, 9008T030, 9015T047, 9017T073, 9063T004, 9064T121, and 9064T122.

    Distribution

    AK, AR, CA, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, MT, NC, NH, NJ, NM, NY, PA, SC, TN, TX, UT, VA, VT, WI, and WV CANADA, FRANCE, and THE NETHERLANDS

    Quantity

    7692 (7615 USA and 77 OUS)