Events

Recall of Device Recall Total knee implant

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
    75715
  • Event Risk Class
    Class 2
  • Event Number
    Z-0711-2017
  • Event Initiated Date
    2016-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151093
  • 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
    A size 4 empowr baseplate was mislabeled as a size 6. the affected lot was laser marked as m6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
  • Action
    The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.

Device

Device Recall Total knee implant
  • Model / Serial
    033T1022
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
  • Product Description
    Empowr Knee System || Product Usage: || Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
  • 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