Events

Recall of BIOMET MICROFIXATION SYSTEM BONE SCREW

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
    54372
  • Event Risk Class
    Class 3
  • Event Number
    Z-1151-2010
  • Event Initiated Date
    2009-10-06
  • Event Date Posted
    2010-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88627
  • 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 is recalling model 01-7293 an model 99-7293-01, 1.5x3.5mm self drilling, low profile, cross drive screw, 5/pk was found to contain a 91-6104 (1.5x4mm high torque, self drilling, cross drive screw.
  • Action
    Biomet Microfixation Issued an "Urgent Medical Device Recall Notice". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425. For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Device

BIOMET MICROFIXATION SYSTEM BONE SCREW
  • Model / Serial
    Lot Numbers: 813480, 114360, 498480, 753270, WL2340 and 031830.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.
  • Product Description
    BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. || Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed.
  • 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