Events

Recall of Tibial Insert

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
    64859
  • Event Risk Class
    Class 2
  • Event Number
    Z-1213-2013
  • Event Initiated Date
    2013-04-01
  • Event Date Posted
    2013-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117199
  • 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 + additive/metal/polymer - Product Code OIY
  • Reason
    U.S. agent contacted director commercial logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. there were 8 e+ tibial inserts of the same lot number in finished goods as the two from the agency. these devices were inspected and all were incorrectly labeled.
  • Action
    The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.

Device

Tibial Insert
  • Model / Serial
    Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of California and International Distribution to the country of Venezuela.
  • Product Description
    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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