Events

Recall of MAKO PN 204588 Camera

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mako Surgical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58464
  • Event Risk Class
    Class 2
  • Event Number
    Z-2232-2011
  • Event Initiated Date
    2010-10-25
  • Event Date Posted
    2011-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99406
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Camera, surgical and accessories - Product Code KQM
  • 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.

Device

MAKO PN 204588 Camera
  • Model / Serial
    Lot #K081867
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: NY only.
  • Product 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.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
  • Source
    USFDA