Events

Recall of Empowr PS Knee System Box Cut Guide

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
    75214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0325-2017
  • Event Initiated Date
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149677
  • 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
    It has been discovered that during empowr ps total knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. the current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
  • Action
    The recalling firm sent a recall notification letter to affected consignees on 9/19/16. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device.

Device

Empowr PS Knee System Box Cut Guide
  • Model / Serial
    202351L01, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US
  • Product Description
    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Manufacturer Parent Company (2017)
    The Blackstone Group LP
  • Source
    USFDA