Events

Recall of EvolisFemoral Sizer Posterior Reference

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
    55465
  • Event Risk Class
    Class 2
  • Event Number
    Z-2095-2010
  • Event Initiated Date
    2009-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90927
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Medacta usa inc is initiating a recall on the femoral sizer, an orthopedic manual surgical instrument, because the "l" and "r" markings are mislabeled which would cause incorrect usage.
  • Action
    The firm, Medacta USA Inc, sent an "Urgent Safety Notification" letter dated August 5, 2009, to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to check their inventory for devices listed, if found, to immediately sequester them and DO NOT use them in surgery. The customers were ask to please pack the affected femoral sizer(s) posterior reference for shipment to Medacta USA. Medacta informed the customers that Medacta USA personnel will contact them by telephone to provide them with an RMA number and the reworked femoral sizer(s) posterior reference will be returned as soon as they are available. If you have any questions, please feel free to contact the Medacta USA office at 805-437-7085 or contact Ms. Heather Neely directly at 805-886-1069.

Device

EvolisFemoral Sizer Posterior Reference
  • Model / Serial
    Model Number: 02.07.10.0215
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of Texas and Idaho and country of France.
  • Product Description
    Evolis-Femoral Sizer Posterior Reference || The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. || The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.
  • 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