Events

Retiro De Equipo (Recall) de Synvasive

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 Synvasive Technology 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
    64810
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1115-2013
  • Fecha de inicio del evento
    2013-04-02
  • Fecha de publicación del evento
    2013-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117111
  • 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
    Blade, saw, general & plastic surgery, surgical - Product Code GFA
  • Causa
    Various reciprocating and oscillating saw blades were incorrectly labeled. the labeling errors include: (1) the pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) the box bar code date does not match the human readable expiration date; and (3) the label incorrectly states use with zimmer/synthes handset and not the zimmer universal power system.
  • Acción
    Zimmer sent a Urgent Device Removal letter dated April 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that received affected product from both Synvasive and from Zimmer Surgical will receive two customer letters, as each letter sets out specific item and lot numbers dependent upon distribution entity. Zimmer Distributors will also receive an e-mail notification. All notifications include a response form for both Synvasive and Zimmer distributors as well as customer consignees to account for product disposition (disposal in the field per facilities' sharps protocol). (1) Notifications will be mailed via Fed Ex to Risk Managers and Zimmer Distributors with inventory. (2) Notifications will be emailed to international geographies. (3) Notifications will be emailed all Zimmer Distributors. (4) A second Fed Ex mailing will be sent to domestic non-responding consignees. (5) Effectiveness phone calls will be made to any remaining domestic non-responding consignees. (6) If a customer reports they have further distributed the product, the secondary consignee identified will receive a notification from Zimmer. The scope of the recall is limited to certain confirmed lots which were shipped to the affected consignees. .E-mails, certified mail receipts, and telephone records will be the firm's course of action in monitoring effectiveness checks. All returns will be stored in a separate area away from regular inventory. Final disposition of returned product is yet to be determined. The firm's recall strategy appears to be adequate. For further questions please call (916) 939-3913.

Device

Synvasive
  • Modelo / Serial
    Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.
  • Descripción del producto
    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA || Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
  • Manufacturer
    Synvasive Technology Inc

Manufacturer

Synvasive Technology Inc
  • Dirección del fabricante
    Synvasive Technology Inc, 4925 Robert J Mathews Pkwy, El Dorado Hills CA 95762-5701
  • 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