Events

Recall of Device Recall BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

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
    51668
  • Event Risk Class
    Class 2
  • Event Number
    Z-1323-2009
  • Event Initiated Date
    2009-03-20
  • Event Date Posted
    2009-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80924
  • 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, fixation, bone - Product Code HRS
  • Reason
    This recall is based on the occurrence of known adverse effects identified in the device instructions for use. bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. implantation of foreign materials can result in an inflammatory response or allergic reaction.
  • Action
    An "Urgent Medical Device Recall Notice" was issued via certified letter or email on March 20, 2009 to consignees. Customers were instructed to immediately remove and return the affected in-stock product to Biomet Microfixation, Inc. Customers were also asked to complete and return the enclosed Inventory Reconciliation sheet via fax (904-741-9425) to the firm, and to notify recipients of any recalled products that had been further distributed. For questions about the recall, contact Biomet Microfixation at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm EST.

Device

Device Recall BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US (including DC and states of AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MI, MO, MN, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA and WI) and countries of Argentina, Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guatemala, Israel, Italy, Lativa, Netherlands, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville, FL. || LactoSorb¿ Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus Excavatum deformities. The LactoSorb¿ Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Pectus Support Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity.
  • 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