Events

Recall of Device Recall Turon

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
    52701
  • Event Risk Class
    Class 2
  • Event Number
    Z-1992-2009
  • Event Initiated Date
    2009-07-20
  • Event Date Posted
    2009-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83676
  • 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
    Shoulder Metal/Polymer Semi-Constrained Uncemented Prosthesis - Product Code MBF
  • Reason
    Product devices used for testing are not identical to what was manufactured. under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.
  • Action
    Firm notified consignees by an Urgent: Medical Device Recall letter, dated July 20, 2009. The letter stated the reason for the recall, asked customers to quarantine, and return the affected product. The enclosed response form needed to be completed and returned as soon as possible. Questions were to be directed to David Harris, Manager of Customer Service at 512-834-6330.

Device

Device Recall Turon
  • Model / Serial
    Lot numbers: 53987943, 53987944, 53987945, 53987946, and 53987947.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of TX, FL, and GA.
  • Product Description
    Turon Revision Glenoid Poly Liner. || The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. || DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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