BEUDAMED
    FDA Recall Terminated

    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

    Recall: Z-1132-2014 · Initiated January 9, 2014

    Recall

    Recall Number
    Z-1132-2014
    Event Number
    67444
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    NPJ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 9, 2014
    Posted
    March 4, 2014
    Terminated
    August 14, 2014
    Address
    2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424

    Description

    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

    Reason

    The product may be mislabeled and could result in the incorrect implant being used.

    Action

    MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. For questions, customers were instructed to call (954) 628-1721. For questions regarding this recall call 954-628-0607.

    Distribution

    Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.

    Quantity

    41 units