Recall of VariLift Bone Plug

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Bone Plug - Product Code JDK
  • Reason
    Device marketed without label warning required in the device's 510(k) approval letter. (in part-warning: this device is not intended for any spinal indications.....).
  • Action
    The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07. Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices.


  • Model / Serial
    Lot #: U101.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide: including direct accounts in CO, KS and TX.
  • Product Description
    VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
  • Manufacturer


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