Events

Retiro De Equipo (Recall) de Sagittal Blade 18.0X0.97X90MM

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
    Recall
  • ID del evento
    75018
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0112-2017
  • Fecha de inicio del evento
    2016-08-17
  • Fecha de publicación del evento
    2016-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149124
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    Stryker instruments is voluntarily recalling the sagittal blade 18.0x.97x90mm due to the potential for a sterile barrier breach in the product's packaging.
  • Acción
    Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM, product number 6118-097-090, lot number 16029017, due to a breach in the packaging causing a breach in sterility. There is a potential for a bone or soft tissue infection which may require medical or surgical intervention. Customer notices were issued via certified mail on 08/17/2016. 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 Sagittal Blades from the affected lot (listed above) are at your facility. Quarantine and discontinue use of the recalled Sagittal Blades. 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 customers dont have any affected product on hand. Note: Customer signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If customers have further distributed this product, please forward the recall letters 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, or scan and email a copy to kellyjo.davis@stryker.com. 6. If the BRF for customer facilities 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. 7. Upon receipt of the recalled product, replacement product will be shipped to customer accounts. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis, 269-389-2921, kellyjo.davis@stryker.com

Device

Sagittal Blade 18.0X0.97X90MM
  • Modelo / Serial
    Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
  • Descripción del producto
    Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 || Product Usage: || Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

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