Events

Recall of EPIK KNEE SYSTEM Angled Insert 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
    38951
  • Event Risk Class
    Class 2
  • Event Number
    Z-0009-2008
  • Event Initiated Date
    2007-08-09
  • Event Date Posted
    2007-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54604
  • 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
    knee prosthesis instrument - Product Code HRY
  • Reason
    Angled insert impactor may scratch tibial insert on the articulating surface, causing increased wear at the damaged site.
  • Action
    Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.

Device

EPIK KNEE SYSTEM Angled Insert Impactor
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Products distributed to direct accounts in CA, FL and MD.
  • Product Description
    EPIK¿ KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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