Events

Recall of Device Recall LactoSorb Heat/Contouring Pen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Microfixation, 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
    61271
  • Event Risk Class
    Class 2
  • Event Number
    Z-1323-2012
  • Event Initiated Date
    2011-11-15
  • Event Date Posted
    2012-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107696
  • 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
    Unit, heating, powered - Product Code IRQ
  • Reason
    On 11/15/2011 biomet microfixation, jacksonville, fl initiated a recall of their acticort heat/contouring pen, model #915-3100, lot #861200. product is incorrectly labeled.
  • Action
    Biomet Microfixation, LLC sent an Urgent Medical Device Safety Alert letter dated November 15, 2011 via E-mail, letter or telephone call to all consignees affected. The letter identified the affected product, problem and actions to be taken. Each consignee was Instructioned to take the following actions: 1) If you have any unopened boxes of the product in question, please place this notice with it; 2) Please fill out the attached Inventory Reconciliation sheet and FAX to the attention of the Global Complaint Coordinator; and 3) If you have further distributed this product , you must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field action notices. For questions please contact Christy Cain at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Device

Device Recall LactoSorb Heat/Contouring Pen
  • Model / Serial
    Lot #861200
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the state of Texas and the country of Japan.
  • Product Description
    The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. || Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA***#915-3100 LOT***QTY 00001, HEAT/CONTOURING PEN AND TIPS***PVC, BRASS***". || Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material.
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Manufacturer Address
    Biomet Microfixation, LLC, 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