Retiro De Equipo (Recall) de Device Recall 6.0mm Round Fluted Bur, Super Long

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 Instruments Div. of Stryker Corporation.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Stryker instruments initiated a voluntary recall of specific lots of round fluted burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
  • Acción
    Stryker initiated a voluntary recall of the Stryker Round Fluted Burs (used with Stryker CORE" System) on June 16, 2016, via certified mail due to the potential for the devices to have tarnishing or corrosion present. Non-responding accounts will be contacted by phone, email, and/or fax as necessary in an effort to obtain signed Business Reply Forms. Affected product will be removed from the field. Further corrective and preventative actions will be determined through the associated CAPA. The existing label will be defaced, packaging will be opened and products will be destroyed. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many affected Round Fluted Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Round Fluted Burs. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4 If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Report any serious adverse events or product quality problems to Stryker Instruments: 1-800-253-3210 Health care professionals and consumers


  • Modelo / Serial
    5190-010-060  Lot Numbers 15231017, 16033017, 16066017
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
  • Descripción del producto
    6.0mm Round Fluted Bur, Super Long
  • Manufacturer


  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source