Events

Recall of Foundation NonPorous Hip System

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
    59739
  • Event Risk Class
    Class 2
  • Event Number
    Z-0418-2012
  • Event Initiated Date
    2011-08-17
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103532
  • 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, hip, semi-constrained, metal/polymer, - Product Code JDI
  • Reason
    The sterility has the potential to be compromised.
  • Action
    Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3. If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.

Device

Foundation NonPorous Hip System
  • Model / Serial
    All devices packaged prior to July 1, 2008. Model/Catalog Number: 460-01-090, 460-01-105, 460-01-120, 460-01-135, 460-01-150, 460-01-165
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
  • Product Description
    FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm || DJO Surgical 9800 Metric Blvd., Austin, TX 78758 || The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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