Events

Retiro De Equipo (Recall) de Device Recall Juggerknot Soft Anchors

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biomet, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    59366
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3109-2011
  • Fecha de inicio del evento
    2011-07-21
  • Fecha de publicación del evento
    2011-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102419
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The device packaging was punctured by the device, resulting in loss of implant sterility.
  • Acción
    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
  • Modelo / 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
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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