Events

Retiro De Equipo (Recall) de TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor

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 Smith & Nephew, Inc. Endoscopy Division.

¿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
    66037
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2229-2013
  • Fecha de inicio del evento
    2013-08-06
  • Fecha de publicación del evento
    2013-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121352
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
  • Acción
    Smith&Nephew; sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.

Device

TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor
  • Modelo / Serial
    50324706 50324707 50324958 50325148 50326624 50336118 50336716 50336759 50337105 50337109 50337112 50339394 50339648 50339653 50339656 50339873 50341613 50343278 50344410 50346095 50350419 50352199 50357080 50358106 50358736 50359998 50361739 50362786 50363871 50366812 50368582 50370504 50372042 50374257 50376594 50378774 50380528 50382637 50384518 50386924 50388022 50390005 50390988 50392388 50395082 50395975 50396667 50398098 50401255 50402220 50404745 50406626 50406675 50408537 50411606 50414330 50415861 50417004 50418086 50422213 50428616 50429266 50429632 50436702 50436747 50436748 50438319 50438651 50438735 50438739 50438918 50445013 50446067 50446068 50446460 50446995 50448591 50450274 50451213 50453452 50453995 50456041 50456190 50457051 50458600 50462057
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
  • Descripción del producto
    TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 || Biodegradable suture anchor
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • Dirección del fabricante
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA