BEUDAMED
    FDA Recall Terminated

    MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.

    Recall: Z-2232-2011 · Initiated October 25, 2010

    Recall

    Recall Number
    Z-2232-2011
    Event Number
    58464
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 25, 2010
    Posted
    May 20, 2011
    Terminated
    November 9, 2011
    Address
    2555 Davie Rd, Ste 110, Davie, FL, 33317-7424

    Description

    MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.

    Reason

    MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7-03127, on November 22, 2010. This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. The recall was initiated after the camera manufacture, NDI, Waterloo, On

    Action

    The firm, MAKO, sent a "RECALL NOTICE" letter dated November 22, 2010, to its customer. The letter described the product, problem and action to be taken. The customer was instructed to complete and return the attached Acknowledgement Form to their MAKOplasty Specialist (MPS) via mail to: MAKO Surgical Corp., Attn: Jim Pomeroy, 2555 Davie Road, Fort Lauderdale, FL 33317. The letter stated that "It is important that the camera be replaced immediately, and MAKO is currently addressing the situation with the camera manufacturer." In addition, MAKO will replace the camera with a camera that is not affected by the recall and verify the customers system to meet the functional specifications. If you have any questions or concerns, please contact your MPS or Sr. Director of Quality Assurance at 954-927-2044 ext 604, and /or Sr. Director, Customer Support at 954-927-2044 ext. 442.

    Distribution

    Nationwide distribution: NY only.

    Quantity

    1