Events

Recall of Device Recall MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

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
    48598
  • Event Risk Class
    Class 2
  • Event Number
    Z-0915-2009
  • Event Initiated Date
    2008-05-02
  • Event Date Posted
    2009-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71699
  • 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
    TACTILE GUIDANCE SYSTEM (TGS) - Product Code HAW
  • Reason
    The product in its current state may fail during use, which would cause the instrument to be in-accurate.
  • Action
    A MAKO employee will visually verify product at each account for any product affected by this recall. In addition, a recall letter dated July 1, 2008 was mailed to users (surgeon and owner of system, e.g. hospital). Customers were instructed to complete the enclosed Acknowledgement form and return it to your Clinical Technical Specialist (CTS) or in the enclosed pre-paid addressed envelope to the Mako Surgical Corporation. Please direct questions to your CTS or call 954-927-2044, extension 604.

Device

Device Recall MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
  • Model / Serial
    Femoral Tray - Model 0150ARR00001, Lot Number/Quantity: 0609038 (6), 06051107 (4), 01010806 (4), 09010108 (2), 06040707-01 (1), 01010107 (3), 01010607 (1), 01010106 (1) and 06040707 (2) and    Tibial Tray - Model 0150ARR00002, Lot Number/Quantity: 06060308 (6), 06061107 (7), 01020866 (2), 01010507 (1), 01020806 (1), 01020107 (3), 09081107 (2) and 01020607 (2).
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
  • Product Description
    Tibial Array and Femoral Array. || Model Number(s): 0150ARR00001 and 0150ARR00002. || Manufactured by: MAKO Surgical, Corp. || The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

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