Events

Recall of Juggerknotless Soft Anchors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    66639
  • Event Risk Class
    Class 2
  • Event Number
    Z-0364-2014
  • Event Initiated Date
    2013-10-10
  • Event Date Posted
    2013-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122873
  • 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
    Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. the implant may skip across the hole or miss the hole during insertion.
  • Action
    Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.

Device

Juggerknotless Soft Anchors
  • Model / Serial
    Catalog:110003173, Lot 127480, 185420, 233500, 233520
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of VA, CA, Ky, and IN
  • Product Description
    Juggerknotless Drill Bit, REF 110003173, || Sterile, Single Use || Product Usage: || The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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