BEUDAMED
    FDA Recall Terminated

    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.

    Recall: Z-1128-2015 · Initiated January 22, 2015

    Recall

    Recall Number
    Z-1128-2015
    Event Number
    70374
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 22, 2015
    Posted
    February 19, 2015
    Terminated
    December 14, 2016
    Address
    2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424

    Description

    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.

    Reason

    When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

    Action

    On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.

    Distribution

    Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.

    Quantity

    228 units