Events

Recall of Device Recall Modular Femoral Neck

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
    48427
  • Event Risk Class
    Class 2
  • Event Number
    Z-1868-2008
  • Event Initiated Date
    2008-05-08
  • Event Date Posted
    2008-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71364
  • 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 - Product Code JDI
  • Reason
    Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
  • Action
    Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form.

Device

Device Recall Modular Femoral Neck
  • Model / Serial
    Lots #53876569, Exp 7/23/2013; 53869022, and lot 53873037
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
  • Product Description
    Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. || Designed to ensure the proper anteversion and femoral head orientation in the acetabulum.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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