Events

Recall of Device Recall Phoenix Cannulated Recon Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EBI, L.P..

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
    51725
  • Event Risk Class
    Class 3
  • Event Number
    Z-2115-2009
  • Event Initiated Date
    2009-03-27
  • Event Date Posted
    2009-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81094
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • Reason
    Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
  • Action
    Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.

Device

Device Recall Phoenix Cannulated Recon Screw
  • Model / Serial
    Catalog number: 14-406110; Lot number 517350
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA and Spain.
  • Product Description
    Phoenix Cannulated Recon Screw; || Ti-Cann PARTL THD Recon Screw || Trauma Fixation Systems; || Rx only || Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 || Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
  • Manufacturer
    EBI, L.P.

Manufacturer

EBI, L.P.
  • Manufacturer Address
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA