Events

Recall of Device Recall 6 HOLE REGULAR DOUBLE Y PLATE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Microfixation, 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
    58199
  • Event Risk Class
    Class 2
  • Event Number
    Z-2385-2011
  • Event Initiated Date
    2010-07-28
  • Event Date Posted
    2011-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98786
  • 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
    Plate, bone - Product Code JEY
  • Reason
    Biomet microfixation, jacksonville, fl is recalling their 1.5 6 hole reg double y, lots 785710, 753120, 693500 and 733600. this product is labeled as 01-7110-k (1.5 6 hole reg double y), however the package contains a 01-7112-k (1.5.6 hold long double y).
  • Action
    The firm, Biomet Microfixation, sent an "URGENT MEDICAL SAFETY ALERT NOTICE" letter dated July 28, 2010 to its customers/distributors. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their stock and ensure that the plates were properly distributed into their trays and that they have the sufficient quantity of plates that they need. In addition, they were instructed to complete and return the attached Inventory Reconciliation form via fax to: Attn: Customer Relations Specialist at 904-741-9425 and notify the recipient of this notice, if they have further distributed the product. If you have any questions, please contact the Customer Relations Specialist at 800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Device

Device Recall 6 HOLE REGULAR DOUBLE Y PLATE
  • Model / Serial
    LOTS: 785710, 753120, 693500 and 733600
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: FL, IN, KY, MT, NC, NE, NY, OH, TX, VA, and WI; and countries including: Argentina, Canada, Colombia, Czech Republic, Japan, Korea, Mexico, Norway, South Africa, Spain and Turkey.
  • Product Description
    ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT*** || This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognathic procedures in the midface.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Manufacturer Address
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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