Events

Retiro De Equipo (Recall) de Device Recall Howmedica Osteonics Corp.

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 Stryker Howmedica Osteonics Corp..

¿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
    64942
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1210-2013
  • Fecha de inicio del evento
    2013-03-28
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117479
  • 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
    Bit, Drill - Product Code HTW
  • Causa
    Stryker orthopaedics has received a report indicating that the scale of the axsos calibrated drill bit 4.3,,x263mm, flat , manufactured by stryker osteosynthesis, is incorrect. the incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.
  • Acción
    Stryker Orthopaedics sent a Urgent Medical Device Removal letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Please inform users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within your organization. 2. Return all affected products available at your location to Stryker Osteosynthesis or Contact Stryker Customer Service. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-252-3635 . 4. Keep a copy of the completed and executed Business Reply Form for your records. Report any adverse events or product quality problems to Stryker Orthopaedics: 1-866-0R-ASSIST. (1-866-672-7747). As we strive for products that meet your expectations for quality and reliability, please do not hesitate to contact us, in case you have any further questions at (201) 831-5970..

Device

Device Recall Howmedica Osteonics Corp.
  • Modelo / Serial
    Catalog number 703615
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.
  • Descripción del producto
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. || The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve."
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA