Events

Recall of Artificial Ligament Fixation Device 15mm, 20mm, 25mm, 30mm, & 35mm TI NS Toggleloc; & 7 PE Ziploop

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Sports Medicine.

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
    48745
  • Event Risk Class
    Class 2
  • Event Number
    Z-0582-2012
  • Event Initiated Date
    2008-04-24
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72047
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Reason
    Six sizes of toggleloc, artificial ligament fixation device, have been manufactured with the suture pull hole drilled in the wrong location on the device. the toggleloc implant is deployed with a suture that pulls the device through the tunnel. the hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. this may caus.
  • Action
    Biomet Sports Medicine sent an "URGENT MEDICAL DEVICE REMOVAL" notice dated May 15, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Customers should contact the firm at 800-535-8692 for questions related to this notice.

Device

Artificial Ligament Fixation Device 15mm, 20mm, 25mm, 30mm, & 35mm TI NS Toggleloc; & 7 PE Ziploop
  • Model / Serial
    Catalog Number: 904720, 904721, 904722 (x2), 904723, 904724, & 904753 Lot Number Identification: L662080, L662090, L763680 - L662100, L662110, L662120 & L705230
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, ID, IL, IN, KS, TX, and WA, and the countries of Australia, Chile, France, Poland, The Netherlands and Turkey.
  • Product Description
    Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM). || Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
  • Manufacturer
    Biomet Sports Medicine

Manufacturer

Biomet Sports Medicine
  • Manufacturer Address
    Biomet Sports Medicine, 4861 E Airport Dr, Ontario CA 91761-7819
  • 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