BEUDAMED
    FDA Enforcement Class II Terminated

    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    Recall: Z-1583-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1583-2016
    Event ID
    73512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    April 28, 2016
    Termination Date
    December 14, 2016
    Address
    2555 Davie Rd Ste 110, N/A, Plantation, FL, 33317-7424, United States

    Description

    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    Reason

    Potential disassociation of the orientation pin.

    Code Info

    Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.

    Distribution

    Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.

    Quantity

    96