Events

Recall of Device Recall Reverse Shoulder Prosthesis device components

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
    37874
  • Event Risk Class
    Class 2
  • Event Number
    Z-1259-2007
  • Event Initiated Date
    2007-03-22
  • Event Date Posted
    2007-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55396
  • 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 device components - Product Code KWS
  • Reason
    Marketed without approval: investigational devices were implanted during an ide study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the ide study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
  • Action
    Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.

Device

Device Recall Reverse Shoulder Prosthesis device components
  • Model / Serial
    0600-145, 0600-147, 0600-188, 0600-189, 0600-190, 0600-213, 0600-218, 0600-219, 0600-220, 506-00-032, and 506-04-032.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
  • Product Description
    Reverse Shoulder Prosthesis (RSP) device component; RSP Socket; Device manufactured by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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