Events

Retiro De Equipo (Recall) de Device Recall Endotec Prothesis Ankle

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 Endotec, 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
    52527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1627-2010
  • Fecha de inicio del evento
    2009-06-05
  • Fecha de publicación del evento
    2010-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85098
  • 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
    Prothesis Ankle - Product Code JWH
  • Causa
    Endotec is recalling b-p hip, b-p shoulder, and b-p knee replacement system devices due to sterility issues involving validation, process variations and test results.
  • Acción
    Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.

Device

Device Recall Endotec Prothesis Ankle
  • Modelo / Serial
    Lot No: 05010101ANN364 05010101BNN364 05010102BNN364 05010103BNN364 05010104ANN364 05010104BNN364 05010105ANN364 05010105BNN364 05010106ANN364 05010106BNN364 05020103DNN377 05020103DNN385 05020103NN377 05020104DNN377 05020104DNN385 05020105DNN376 05020105DNN385 05020113ANN377 05020114ANN377 05020123DNN377 05020123DNN385 05020124DNN377 05020124DNN385 05020125DNN376 05020125DNN385 05020143DNN377 05020143DNN385 05020145DNN385 05020163NN377 05020183DNN377 05030101BNN364 05030102BNN364 05030103BNN358 05030103BNN364 05030104A2NN364 05030104ANN364 05030104BNN358 05030104BNN364 05030105BNN364 05030106BNN364  05020106DNN376  05020115ANN376  05020116ANN376  05020126DNN376  05020146DNN376  05020165DNN376  05020166DNN376  05020185DNN376  05020186DNN376
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
  • Descripción del producto
    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. || BP Ankle System, B-P Type II Talar Ankle Component: || Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, || Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, || Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, || Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, || Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, || Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. || BP Ankle System, BP Type II Ankle Bearing: || 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, || 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, || 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, || 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, || 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, || 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, || 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, || 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, || 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, || 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, || 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, || 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. || 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. || 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. || 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. || 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. || 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. || 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. || 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. || 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. || 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. || BP Ankle System, B-P Type II Tibial Ankle Component || Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, || Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, || Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, || Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, || Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, || Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.
  • Manufacturer
    Endotec, Inc.

Manufacturer

Endotec, Inc.
  • Dirección del fabricante
    Endotec, Inc., 2546 Hansrob Rd, Orlando FL 32804-3318
  • Empresa matriz del fabricante (2017)
    Cellumed Co., Ltd.
  • Source
    USFDA