Events

Retiro De Equipo (Recall) de Stryker Spine Torque Wrench

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 Spine.

¿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
    66657
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0375-2014
  • Fecha de publicación del evento
    2013-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122908
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
  • Acción
    Stryker sent an Urgent Medical Device Removal Notification letter dated September 25, 2013, with product accountability forms to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify any affected product, reconcile any Torque Wrenches with Catalog Number with Lot Numbers referenced in the letter. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 855-632-9049 or you email it to Spine-RegulatoryActions@Stryker.com. Customers were asked to return the affected product using the enclosed mailing label to: RECALL RA 2013-105 Stryker Spine 59 Route 17 South, Allendale, New Jersey 07401 branches/agencies, the field and surgeons via Fed Ex on starting on 9/24/2013. For questions regarding this recall call 201-760-8298. Stryker sent another Urgent Medical Device Removal Notification Letter dated 1/29/2014 which included additional lots and one product.

Device

Stryker Spine Torque Wrench
  • Modelo / Serial
    Medical Device Listing Number E207315  1) XIA Torque Wrench Catalog # 03807028 Lot # 127510, 092793, 097089, 11E038, 11E039, 11E040, 11E041, 123746, 127179, &12D012  2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042, 11E044, 11E047, 098525, 118823, 11E043, 11E045, 11E046, 11E048, 127647, R127647, 12A646, & R12A646  3) XIA Elegance Short Torque Wrench Catalog # 482397028 Lot # 11A957, 11E035, 11E036, R11E036, & 121098  4) Mantis Redux Torque Wrench Reference Number 48287028 Lot # 098401, 125708, 125709, 127051 & 12A641
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
  • Descripción del producto
    Stryker || 1) XIA Torque Wrench || 2) XIA 3 Torque Wrench || 3) XIA Elegance Short Torque Wrench || Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 || http://www.stryker.com || Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 || XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Dirección del fabricante
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA