Events

Retiro De Equipo (Recall) de Osteoraptor 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-2225-2013
  • 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=121335
  • 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
    Staple, fixation, bone - Product Code JDR
  • 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

Osteoraptor Suture Anchor
  • Modelo / Serial
    50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697
  • 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
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 || 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