BEUDAMED
    FDA Recall Terminated

    200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    Recall: Z-0064-2010 · Initiated July 17, 2009

    Recall

    Recall Number
    Z-0064-2010
    Event Number
    53033
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 17, 2009
    Posted
    October 19, 2009
    Terminated
    May 12, 2010
    Address
    2555 Davie Rd, Ste 110, Davie, FL, 33317-7424

    Description

    200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    Reason

    Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System.

    Action

    A Recall Notice, dated July 15, 2009, was sent to owners of the RIO system (hospital OR staff) with a signed acknowledgement returned to MAKO. Surgeons using the RIO system during the recall time period, regardless of whether their system has already been upgraded, are given the notification letter and asked to sign and return the acknowledgement memo. The letter stated that customers' RIO will be upgraded to replace the potentially faulty cable with a new cable. Their MAKOplasty Specialist (MPS) will notify them when their system was scheduled to have their fiber optic cable upgrade. The upgrade will be installed by a Field Service Engineer (FSE) free of charge and the RIO will be completely tested prior to being returned to service. Customers should direct questions or concerns to their MPS, FSE, or Jim Pomeroy, who can be reached at 954-927-2044.

    Distribution

    Nationwide Distribution

    Quantity

    23