Events

Recall of GMK Intramedullary Extension Rod 100 mm

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

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
    69493
  • Event Risk Class
    Class 2
  • Event Number
    Z-0202-2015
  • Event Initiated Date
    2014-09-22
  • Event Date Posted
    2014-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130759
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Medacta has registered in its database 3 cases of breakage of the gmk intramedullary extension rod 100 mm, code 02.07.10.0162.
  • Action
    Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.

Device

GMK Intramedullary Extension Rod 100 mm
  • Model / Serial
    Model Number: 02.07.10.0162
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
  • Product Description
    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. || Rod to obtain correct leg alignment during total knee replacement.
  • Manufacturer
    Medacta Usa

Manufacturer

Medacta Usa
  • Manufacturer Address
    Medacta Usa, 1552 W Carroll Ave, Chicago IL 60607-1012
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA