Events

Recall of Device Recall Encore Reverse Shoulder Prosthesis

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
    32909
  • Event Risk Class
    Class 2
  • Event Number
    Z-1566-05
  • Event Initiated Date
    2005-07-28
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41060
  • 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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Reason
    Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
  • Action
    Recall was initiated by letter to sales agents on 07/28/2005.

Device

Device Recall Encore Reverse Shoulder Prosthesis
  • Model / Serial
    Catalog number: 506-00-006, lot numbers: 260212, 260222, and 244642;  Catalog number: 506-00-007, lot number: 250272;  Catalog number: 506-00-008, lot numbers: 260242, 254342, 260252, 244662, and 244312;  Catalog number: 507-06-175, lot numbers: 261832, 244732, 967721, and 006192;  Catalog number: 507-08-175, lot numbers: 261842, 241392, 872681, and 872671
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Product Description
    Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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