Events

Retiro De Equipo (Recall) de Anspach Cutters and Attachments

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 The Anspach Effort, 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
    67124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0708-2014
  • Fecha de inicio del evento
    2012-10-26
  • Fecha de publicación del evento
    2014-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124743
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Causa
    During a recent review of documentation anspach determined that the current directions for use for the mca cutting burrs and mca micro curved attachment do not provide clear details regarding the intended use specifically for the mca burrs. the mca burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. the use of the device in dense bone removal may result in cu.
  • Acción
    Anspach sent an Urgent Medical Removal letter dated October 26, 2012, to all affected customers. The letter stated that they were initiating a Medical Device removal regarding the MCA Cutting Burrs. During a recent review of documentation it was determined that the current directions for use for the MCA cutting burrs (item 18-0079) and MCA Micro Curved Attachment (item 18-0060) did not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/ burr fracture. If a fracture occurs, contact Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. If the procedure was done successfully, no additional patient follow up is necessary. Customer Immediate Actions: 1. Please remove and return any MCA items from your inventory immediately. 2. Complete the attached reply form indicating your receipt of this letter. Return the completed form by fax or email to the number or email address provided on the form. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Customers with questions were instructed to contact Anspach Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. For questions regarding this recall call 1-800-327-6887.

Device

Anspach Cutters and Attachments
  • Modelo / Serial
    All Lots for  MCA - MICRO CURVED ATTACHMENT,  MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,  MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM,  MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM,  MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM,  MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM,  MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,  MCA5-1SB - lMM FLUTED BALL, 5.6CM,  MCA5-1SD - lMM DIAMOND BALL, 5.6CM,  MCA5-2SB - 2MM FLUTED BALL, 5.6CM,  MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,  MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,  MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,  MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,  MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,  MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,  MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,  MCA7-1SB - lMM FLUTED BALL, 7.3CM,  MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM,  MCA7-2SB - 2MM FLUTED BALL, 7.3CM and  MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
  • Descripción del producto
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) || MCA - MICRO CURVED ATTACHMENT, || MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, || MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, || MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, || MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, || MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, || MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, || MCA5-1SB - lMM FLUTED BALL, 5.6CM, || MCA5-1SD - lMM DIAMOND BALL, 5.6CM, || MCA5-2SB - 2MM FLUTED BALL, 5.6CM, || MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, || MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, || MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, || MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, || MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, || MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, || MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, || MCA7-1SB - lMM FLUTED BALL, 7.3CM, || MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, || MCA7-2SB - 2MM FLUTED BALL, 7.3CM and || MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. || The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Dirección del fabricante
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA