Events

Recall of Device Recall Optigun Ratchet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BIOMET FRANCE S.A.R.L..

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
    71365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1744-2015
  • Event Initiated Date
    2015-05-14
  • Event Date Posted
    2015-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137454
  • 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
    Dispenser, cement - Product Code KIH
  • Reason
    The pin which maintains the knob button, may disconnect and become lost. this may result in a delay of surgery to obtain a new optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
  • Action
    BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.

Device

Device Recall Optigun Ratchet
  • Model / Serial
    Catalog number: 419500 Lot number: 0101296012
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MD only
  • Product Description
    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
  • Manufacturer
    BIOMET FRANCE S.A.R.L.

Manufacturer

BIOMET FRANCE S.A.R.L.
  • Manufacturer Address
    BIOMET FRANCE S.A.R.L., plateau de lautagne, valence cedex 9, Valence Cedex 9 France
  • 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