Events

Recall of Device Recall Polaris Translation Screw System

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
    66300
  • Event Risk Class
    Class 2
  • Event Number
    Z-0359-2014
  • Event Initiated Date
    2013-08-22
  • Event Date Posted
    2013-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121961
  • 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
    Polaris translation screw failures were recently reported to biomet spine. these failures are generally described as dissociation of the screw head from the shaft of the polaris translation screw.
  • Action
    Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.

Device

Device Recall Polaris Translation Screw System
  • Model / Serial
    Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the  SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution including Puerto Rico.
  • Product Description
    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. || Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
  • 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