Events

Recall of Phoenix Retrograde Femoral Nail

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

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
    65210
  • Event Risk Class
    Class 2
  • Event Number
    Z-1547-2013
  • Event Initiated Date
    2013-04-29
  • Event Date Posted
    2013-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118267
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Biomet trauma ("biomet") has initiated a recall of retrograde femoral connecting bolt, which involves part number 14-442021. the connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (part number: 41024) near the edge of the tolerance. if the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su.
  • Action
    Biomet sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 29, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to: immediately locate and remove the identified affected device(s), carefully follow the instructions on the enclosed "FAX Back Response Form", fax a copy of the Response Form to 574-372-1683 prior to return of product, use priority carrier for your shipment, if you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. For questions call 574-372-1570.

Device

Phoenix Retrograde Femoral Nail
  • Model / Serial
    Catalog number: 14-442021 and lot number:757910
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.
  • Product Description
    Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. || Product Usage: || The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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