Events

Retiro De Equipo (Recall) de BIORAPTOR" 2.9 mm 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-2215-2013
  • 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=121303
  • 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
    Screw, fixation, bone - Product Code HWC
  • 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

BIORAPTOR" 2.9 mm Suture Anchor
  • Modelo / Serial
    50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368,  50276253, 50276254, 50276805, 50277029, 50277294, 50277527, 50277929,  50278456, 50278571, 50278899, 50279282, 50279628, 50279887, 50280270,  50280509, 50280951, 50281119, 50281654, 50281988, 50282538, 50282785,  50283315, 50283661, 50284261, 50284507, 50285047, 50285232, 50286292,  50286603, 50287484, 50287742, 50287951, 50288412, 50288413, 50288709, 50288711, 50289018, 50289361, 50289598, 50290037,50290863, 50291536, 50291656, 50292239, 50292240, 50292919, 50293285, 50293609, 50293897 50294168, 50294377, 50295055, 50295263 50296219 50296742 50297227 50297778 50297779 50297780 50298062 50298419 50298786 50299246 50299545 50299546 50299826 50300216 50300804 50301267 50301404 50302151 50302685 50303058 50303427 50303788 50303941 50304178 50304532 50305224 50305593 50306159 50306607 50306999 50307177 50307178 50307323 50307855 50308129 50308350 50308876 50309006 50309569 50309929 50310088 50310360 50310603 50311024 50311465 50311593 50312088 50312508 50312903 50313096 50313194 50313433 50313434 50313810 50313981 50314087 50314275 50314383 50314587 50314734 50314912 50315220 50315412 50315573 50316170 50316287 50316663 50316991 50317294 50317333 50317334 50319134 50319316 50319548 50319721 50320087 50320539 50320883 50321123 50321480 50321923 50322389 50322921 50323075 50323255 50323447 50323635 50323776 50324607 50326329 50327629 50327993 50331045 50328867 50329238 50331335 50331336 50331537 50332615 50332903 50333951 50334376 50335473 50336653 50337963 50338375 50339635 50340038 50340416 50340763 50342101 50343001 50344257 50345538 50347525 50348062 50348915 50349098 50349263 50350688 50350689 50350836 50352820 50353935 50354580 50355436 50356119 50356623 50357088 50357393 50357564 50357945 50358202 50358558 50359337 50360155 50360278 50361746 50362228 50363184 50363885 50364586 50365181 50366145 50367196 50367857 50369186 50370317 50370991 50371619 50372060 50373120 50373578 50374500 50375710 50376426 50376982 50377966 50378141 50378906 50379638 50380808 50381014 50382645 50383518 50385488 50388028 50388735 50391247 50392262 50393194 50393195 50393328 50394070 50395083 50396301 50396306 50397055 50397697 50398394 50399613 50400932 50401260 50402476 50403935 50405215 50406205 50407446 50410767 50411908 50412270 50413576 50415461 50416150 50417011 50418094 50420319 50423595 50423956 50426322 50427033 50428117 50429370 50429371 50429656 50430184 50430404 50434435 50436746 50437585 50438204 50439582 50441442 50441680 50443183 50443859 50445451 50445521 50445522 50446168 50447915 50448596 50449837 50450220 50451518 50451942 50455628 50457777 50458924 50461408
  • 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
    BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 || 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