Events

Recall of Broach Handle, manual orthopedic surgical instrument

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
    53337
  • Event Risk Class
    Class 2
  • Event Number
    Z-0267-2013
  • Event Initiated Date
    2008-10-13
  • Event Date Posted
    2012-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85292
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Reason
    Medacta usa inc has initiated a recall on the quadra s offset broach handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
  • Action
    Medacta USA, sent a Urgent Safety Notification letter dated October 13, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter informed the customers of the lot numbers on recall and the reference numbers. The recall was initiated because the offset broach handles contain a lever mechanism that is connected to the locking axis by means of a metallic wire. The rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. For further questions please call (858) 705-0350.

Device

Broach Handle, manual orthopedic surgical instrument
  • Model / Serial
    Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
  • Product Description
    Quadra S Offset Broach Handle || The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Manufacturer Address
    Medacta Usa Inc, 4725 Calle Quetzal Unit B, Camarillo CA 93012-9101
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA