Events

Recall of Device Recall EMPOWR Porous Knee System TIBIAL PUNCH, LARGE

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
    78727
  • Event Risk Class
    Class 2
  • Event Number
    Z-0329-2018
  • Event Initiated Date
    2017-12-12
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160234
  • 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
    The locking punch guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
  • Action
    The field safety notice was disseminated by email on 12/12/2017. The notice stated the following: "DJO Sales Agents Action: Please review the bulletin that is provided with this notice. This bulletin contains new instructions on the use of the Locking Punch Guide and Punch. Please ensure your surgeons are familiar with this information. DJO Surgical then requires that you complete the attached acknowledgment and email it to teffany.hutto@djoglobal.com. Please have this form returned by December 15, 2017 Once redesigned guides are available, they will be exchanged through a separate field action."

Device

Device Recall EMPOWR Porous Knee System TIBIAL PUNCH, LARGE
  • Model / Serial
    Lot 252564
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    One medical device distributor in California.
  • Product Description
    EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
  • 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