BEUDAMED
    FDA Recall Terminated

    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

    Recall: Z-1411-2017 · Initiated December 22, 2016

    Recall

    Recall Number
    Z-1411-2017
    Event Number
    76158
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 22, 2016
    Terminated
    August 6, 2019
    Address
    2555 Davie Rd, Ste 110, Davie, FL, 33317-7424

    Description

    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

    Reason

    Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

    Action

    Letter from Stryker dated 1/28/2017 was sent via USP Next Day Air with return receipt to all their customers. With the following actions; Inform users of this medical device correction and forwar this notice to all those individuals who need to be aware within your organization and return the attached Business Replay Form within 5 business days, to Fax 844-782-5561 or via e-mail to [email protected]

    Distribution

    US nationwide distribution.

    Quantity

    777