BEUDAMED
    FDA Enforcement Class II Terminated

    Restoris MCK Onlay Insert Extractor.

    Recall: Z-2051-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2051-2018
    Event ID
    80016
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    January 19, 2018
    Classification Date
    June 1, 2018
    Termination Date
    September 16, 2020
    Address
    2555 Davie Rd Ste 110, N/A, Davie, FL, 33317-7424, United States

    Description

    Restoris MCK Onlay Insert Extractor.

    Reason

    Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

    Code Info

    Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912. Expanded scope: Lot No. 19150517, 19160517.

    Distribution

    Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.

    Quantity

    575 units total (400 US, 175 OUS)