Events

Recall of Biomet Polaris 5.5

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

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
    63653
  • Event Risk Class
    Class 2
  • Event Number
    Z-0536-2013
  • Event Date Posted
    2012-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114420
  • 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
    Screwdriver - Product Code HXX
  • Reason
    Broken screw insertor hardness was measured and found to be below the acceptable limits.
  • Action
    Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.

Device

Biomet Polaris 5.5
  • Model / Serial
    Lot Numbers 540199, 540199-1
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including the states of MO, TX, and IN.
  • Product Description
    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Manufacturer Address
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA