Events

Recall of Encore Reverse Shoulder Prosthesis (RSP) Socket Insert

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
    44800
  • Event Risk Class
    Class 2
  • Event Number
    Z-0184-2008
  • Event Initiated Date
    2007-08-08
  • Event Date Posted
    2007-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64399
  • 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 Prothesis Socket Insert - Product Code KWS
  • Reason
    Devices mislabeled; one lot of size 36 standard rsp socket inserts were labeled as size 40 standard rsp sockets and vice versa.
  • Action
    Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling firm.

Device

Encore Reverse Shoulder Prosthesis (RSP) Socket Insert
  • Model / Serial
    Lot #: 602032.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.
  • Product Description
    Encore¿ Reverse¿ Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; 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