Events

Recall of Device Recall Juggerknot 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
    59366
  • Event Risk Class
    Class 2
  • Event Number
    Z-3109-2011
  • Event Initiated Date
    2011-07-21
  • Event Date Posted
    2011-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102419
  • 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
    The device packaging was punctured by the device, resulting in loss of implant sterility.
  • Action
    Biomet Sports Medicine notified distributor accounts by telephone on July 08, 2011 with instructions to quarantine all lots of the recalled product. Urgent Medical Device Recall Notice letters dated July 21, 2011 were sent to all affected customers. The letter identified the recalled product, problem, and actions to be taken. The customers were instructed to immediately locate and discontinue use of the recalled product. The distributors are advised to communicate this notice to their customers if the recalled products were further distributed. The letter also states that distributors are responsible for the return of the recalled product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Customers were instructed to provide phone confirmation at 800-348-9500, extension 3755 or 3756, when the recall notice is received. Further questions should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8 AM to 5 PM.

Device

Device Recall Juggerknot Soft Anchors
  • Model / Serial
    Lot #: M050020, Ml02470, M205970, M206170, M335840, M451670, M554290, M592790, M906510, M050030, M102480, M205980, M206180, M335860, M451680, M554300, M596210, M906540, M050040, M102490, M205990, M206200, M335870, M451690, M554310, M666350, M906550, M050050, M102500, M206000, M213400, M336170, M451700, M555140, M666360, M974690, M050060, M102510, M206010, M213410, M350540, M475050, M571420, M725330, M974720, M050070, M102520, M206030, M213420, M350550, M479960, M571560, M725340, M050080, M102530, M206060, M248050, M350560, M506760, M571570, M727850, M051940, M102540, M206070, M248060, M350570, M513940, M571580, M762160, M051950, M185150, M206080, M248070, M351000, M537410, M571600, M802400, M051960, M185160, M206090, M248080, M354670, M554260, M571730, M802410, M051970, M205940, M206140, M248090, M451650, M554270, M571760, M802420, M072920, M205960, M206150, M248100, M451660, M554280, M571800, and M860160
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.
  • Product Description
    REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. || Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
  • 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