BEUDAMED
    FDA Recall Terminated

    Robotic Arm Interactive Orthopedic System (RIO)

    Recall: Z-1508-2016 · Initiated April 30, 2014

    Recall

    Recall Number
    Z-1508-2016
    Event Number
    73202
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 30, 2014
    Posted
    April 18, 2016
    Terminated
    July 24, 2019
    Address
    2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424

    Description

    Robotic Arm Interactive Orthopedic System (RIO)

    Reason

    Revision of the field manual

    Action

    As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.

    Quantity

    249