Events

Retiro De Equipo (Recall) de Device Recall Anspach Single Use, Sterile Bone Cutting Burrs

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
    59837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0101-2012
  • Fecha de inicio del evento
    2008-05-19
  • Fecha de publicación del evento
    2011-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104175
  • 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
    Burr, orthopedic - Product Code HTT
  • Causa
    The anspach effort, inc. initiated a recall on may 6, 2008 for their sterile bone cutting burrs. all affected customers were notified of the recall by letter dated 5/29/2008.
  • Acción
    The firm, Anspach sent an "URGENT PRODUCT REMOVAL" letter on May 29, 2008, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for all products listed on the attached "Product Replacement Form." Upon visual inspection if the pouch is sealed on both ends it is sterile. If one end of the pouch is not sealed it is non-sterile and should be returned for credit or replacement. 2) Complete the "Product Replacement Form" by indicating the quantity returned, and whether the customer would prefer to have their returned devices replaced, or their account credited. 3) Place products to be returned in a box and mark the box with the Return Authorization Number on the "Product Replacement Form." 4) Use the Anspach FedEx account number listed on the form to return the unused devices with the completed "Product Replacement Form." Following receipt of the form, Anspach will process the request immediately. For questions related to the product replacement, please contact Customer Service at 800-327-6887. For questions related to the Voluntary Removal, please contact Anspach Regulatory Affairs and Quality Assurance at 800-327-6887.

Device

Device Recall Anspach Single Use, Sterile Bone Cutting Burrs
  • Modelo / Serial
    Lot number: B133005432.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: CA, CO, FL, GA, IA, ID, SC, MA, MD, MI, MO, MN, MS, NY, OH, OR, PA, TN, TX, and WI, and the countries of: Africa, Netherlands, Panama, South Korea, Spain, and United Kingdom.
  • Descripción del producto
    "***REF S-35DC***3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" || Lot number: B133005432. || Product Usage: Cutting and shaping bone including bones of the spine and cranium.
  • 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