Events

Recall of 6.5mm Cancellous Bone Screw

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
    63321
  • Event Risk Class
    Class 2
  • Event Number
    Z-0139-2013
  • Event Date Posted
    2012-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113489
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    A product complaint was received where a size 20 screw was labeled as size 30. after receipt, measurement of the screw determined it to be a size 25. further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. it was thought that all of these screws were found in-house and were contained, but it was determined later that on.
  • Action
    Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255

Device

6.5mm Cancellous Bone Screw
  • Model / Serial
    Model Number 10-55-025, Lot Number 006A1057.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution only to CA.
  • Product Description
    6.5mm Cancellous Bone Screw || Intended to be used for the fixation of the acetabular shell or fracture repair.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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