Events

Recall of MectaLIF Oblique Handle

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
    69693
  • Event Risk Class
    Class 2
  • Event Number
    Z-0225-2015
  • Event Initiated Date
    2014-10-21
  • Event Date Posted
    2014-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131393
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    The mectalif oblique handle has the laser marking "medial" on the incorrect side and could result in incorrect insertion of the device during surgery.
  • Action
    Medacta sent an URGENT MEDICAL DEVICE RECALL letter dated October 21, 2014 were via e-mail to all sales representatives and distributors. The letters included instructions for the sales represetantives and distributors to: 1) check their inventory for the recalled devices; 2) immedaitely sequester the recalled devices and do not use them during surgery; 3) if the devices have been further distributed, inform them of the recall; and, 4) replacement devices will be provided. Customers with questions can contact Medacta USA at 805-910-6511.

Device

MectaLIF Oblique Handle
  • Model / Serial
    Model Number: 03.22.10.0262;  Lot Number: 1314256
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
  • Product Description
    The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
  • Manufacturer
    Medacta Usa

Manufacturer

Medacta Usa
  • Manufacturer Address
    Medacta Usa, 1556 W Carroll Ave, Chicago IL 60607-1012
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA