Events

Recall of Device Recall Quadra Trial Broach size 0

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

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
    64160
  • Event Risk Class
    Class 2
  • Event Number
    Z-0791-2013
  • Event Initiated Date
    2012-12-17
  • Event Date Posted
    2013-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115467
  • 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
    Quadra Trial Broach size 0 - Product Code MEH
  • Reason
    The tip of the quadra trial broach size 0, broke during a surgery.
  • Action
    Medacta sent a Urgent Safety Notification letter dated December 13, 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to check inventory for affected product and contact QA@medacta.us.com for an RMA# to return items to Medacta USA. A new version of the recalled product will be provided to all affected customers. For questions call 805-437-7085 x26.

Device

Device Recall Quadra Trial Broach size 0
  • Model / Serial
    Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
  • Product Description
    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. || Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Manufacturer Address
    Medacta Usa Inc, 4725 Calle Quetzal Ste B, Camarillo CA 93012-8429
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA