Events

Recall of Phoenix Antegrade Femoral Nail Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    79146
  • Event Risk Class
    Class 2
  • Event Number
    Z-0774-2018
  • Event Initiated Date
    2017-09-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161442
  • 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
    Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
  • Action
    On September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071

Device

Phoenix Antegrade Femoral Nail Instrument
  • Model / Serial
    Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution includes US Nationwide.
  • Product Description
    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer 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