Events

Recall of Device Recall Femoral Cut Block

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
    71663
  • Event Risk Class
    Class 2
  • Event Number
    Z-2262-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138622
  • 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
    Template - Product Code HWT
  • Reason
    The markings on the distal face of the instruments are mis-oriented by 180¿. this includes anterior and posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. the cut block is not symmetric, so correct orientation of the instrument in the a/p direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.
  • Action
    DJO Surgical sent an " Urgent Field Safety Notice" dated June 30, 2015, to the affected customer. The recalling firm requested the customer return the affected product for a replacement. For further questions, please call (512) 834-6302.

Device

Device Recall Femoral Cut Block
  • Model / Serial
    Lot 53839799 and 414012
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to TX and GA.
  • Product Description
    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
  • 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