Events

Retiro De Equipo (Recall) de Device Recall Versys Beaded Fullcoat Femoral Stem

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 Zimmer, 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
    65799
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0070-2014
  • Fecha de inicio del evento
    2013-08-30
  • Fecha de publicación del evento
    2013-10-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120669
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    The low density polyethylene (ldpe) bag used to package implants adheres to the highly polished surface of the devices.
  • Acción
    August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.

Device

Device Recall Versys Beaded Fullcoat Femoral Stem
  • Modelo / Serial
    Part Number Range: 00-7843-011/022-06/56
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • Descripción del producto
    Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT || POR FULL-CT FEM ST 12X160MM || VERSYS BEADED FC 12X200MM 8 ST || POR FULLCT FEM ST 12 LOW EXT || POR FLCT FEM ST 12.0X190 STR || POR FULLCT FEM ST 12 EXT || POR FULL-CT FEM ST LM 12X160MM || POR FULLCT LM FEM ST 12 EXT || POR FULL-CT FEM ST 13X160MM || VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL || POR FULLCT FEM ST 13 LOW EXT || POR FLCT FEM ST 13.5X190 STR || POR FULLCT FEM ST 13 EXT || POR FULL-CT FEM ST LM 13X160MM || POR FULLCT LM FEM ST 13 EXT || POR FULL-CT FEM ST 14X160MM || VERSYS BEADED FC 14X200MM 8 ST || POR FULLCT FEM ST 14 LOW EXT || POR FULLCT FEM ST 14 EXT || POR FULL-CT FEM ST LM 14X160MM || POR FULLCT LM FEM ST 14 EXT || POR FULL-CT FEM ST 15X160MM || VERSYS BEADED FC 15X200MM 8 ST || POR FULLCT FEM ST 15 LOW EXT || POR FLCT FEM ST 15.0X190 STR || POR FLCT FEM ST 15.0X250 STR || POR FULLCT FEM ST 15 EXT || POR FULL-CT FEM ST LM 15X160MM || POR FULLCT FEM ST 15 XEXT || POR FULLCT LM FEM ST 15 EXT || POR FULL-CT FEM ST 16X160MM || VERSYS BEADED FC 16X200MM 8 ST || POR FULLCT FEM ST 16 LOW EXT || POR FLCT FEM ST 16.5X190 STR || POR FLCT FEM ST 16.5X250 STR || POR FULLCT FEM ST 16 EXT || POR FULL-CT FEM ST LM 16X160MM || POR FULLCT FEM ST 16 XEXT || POR FULLCT LM FEM ST 16 EXT || POR FULL-CT FEM ST 17X160MM || VERSYS BEADED FC 17X200MM 8 ST || POR FULLCT FEM ST 17 EXT || POR FULL-CT FEM ST LM 17X160MM || POR FULLCT FEM ST 17 XEXT || POR FULLCT LM FEM ST 17 EXT || POR FULL-CT FEM ST 18X160MM || VERSYS BEADED FC 18X200MM 8 ST || POR FLCT FEM ST 18.0X190 STR || POR FLCT FEM ST 18.0X250 STR || POR FULLCT FEM ST 18 EXT || POR FULL-CT FEM ST LM 18X160MM || POR FULLCT FEM ST 18 XEXT || POR FULLCT LM FEM ST 18 EXT || POR FULL-CT FEM ST 19X160MM || POR FLCT FEM ST 19.5X190 STR || POR FLCT FEM ST 19.5X250 STR || POR FULLCT FEM ST 19 EXT || POR FLCT FEM STEM LM 19X160MM || POR FULLCT FEM ST 19 XEXT || POR FULLCT LM FEM ST 19 EXT || POR FULL-CT FEM ST 20X160MM || VERSYS BEADED FC 20X200MM 8 ST || POR FULLCT FEM ST 20 EXT || POR FLCT FEM STEM LM 20X160MM || POR FULLCT FEM ST 20 XEXT || POR FULLCT LM FEM ST 20 EXT || POR FULL-CT FEM ST 21X160MM || POR FLCT FEM ST 21.0X190 STR || POR FLCT FEM ST 21.0X250 STR || POR FULLCT FEM ST 21 EXT || POR FLCT FEM STEM LM 21X160MM || POR FULLCT FEM ST 21 XEXT || POR FULLCT LM FEM ST 21 EXT || POR FULLCT FEM STEM 22X160MM || POR FLCT FEM ST 22.5X190 STR || POR FLCT FEM ST 22.5X250 STR || POR FULLCT FEM ST 22 EXT || POR FLCT FEM STEM LM 22X160MM || POR FULLCT FEM ST 22 XEXT || POR FULLCT LM FEM ST 22 EXT. || Used in total hip replacement.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA