BEUDAMED
    FDA Recall Terminated

    Restoris MCK Onlay Insert Extractor.

    Recall: Z-2051-2018 · Initiated January 19, 2018

    Recall

    Recall Number
    Z-2051-2018
    Event Number
    80016
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    NPJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 19, 2018
    Posted
    June 1, 2018
    Terminated
    September 16, 2020
    Address
    2555 Davie Rd, Ste 110, Davie, FL, 33317-7424

    Description

    Restoris MCK Onlay Insert Extractor.

    Reason

    Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

    Action

    Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand. On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification.

    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)