Events

Recall of Impactor

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

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
    49116
  • Event Risk Class
    Class 2
  • Event Number
    Z-2466-2008
  • Event Initiated Date
    2008-08-04
  • Event Date Posted
    2008-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72797
  • 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 - Product Code JWH
  • Reason
    Complaints received regarding the fracture of the nitronic 60 screw on the tibial fixed impactor during surgery.
  • Action
    Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.

Device

Impactor
  • Model / Serial
    All Revision A and Revision B Impactors.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL and TX and OUS: Japan.
  • Product Description
    FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA