Events

Recall of MaxAn 4.0mm and 4.5mm fixed screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Spine, 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
    72312
  • Event Risk Class
    Class 2
  • Event Number
    Z-0203-2016
  • Event Date Posted
    2015-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140568
  • 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
    appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    The packaging of 4.5 mm diameter maxan screws identifies/labels the screws as 4.0 mm diameter screws.
  • Action
    Zimmer Biomet Spine sent an Urgent Medical Device Recall Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has already been implanted, written confirmation of this will be required and the necessary parties will be contacted. They will store returned product in quarantine in an isolated location until they can undergo inspection to verify if they are conforming or not and then will be destroyed or retained. Necessary parts will be destroyed so that it is visually obvious they are no longer functional. For further questions call (303) 443-7500 ext.244.

Device

MaxAn 4.0mm and 4.5mm fixed screw
  • Model / Serial
    P/N: 14-521550; Lot Numbers: 463870;  P/N: 14-521548; Lot Numbers: J86056;  P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : NY, MO, and FL
  • Product Description
    MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Manufacturer Address
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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