Events

Recall of Device Recall Turon Humeral Head Trials

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
    57210
  • Event Risk Class
    Class 2
  • Event Number
    Z-0798-2011
  • Event Initiated Date
    2010-11-05
  • Event Date Posted
    2010-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95605
  • 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
    orthopedic instrument - Product Code KWS
  • Reason
    Complaints of fracturing were reported for trial products.
  • Action
    Encore Medical notified consignees by letter on 11/5/2010.

Device

Device Recall Turon Humeral Head Trials
  • Model / Serial
    Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034,  804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, SC, GA
  • Product Description
    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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