Events

Retiro De Equipo (Recall) de Device Recall Acumed Tension Band Pin

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 Acumed LLC.

¿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
    67885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1516-2014
  • Fecha de inicio del evento
    2014-03-26
  • Fecha de publicación del evento
    2014-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126602
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Certain lots of acumed tension band pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
  • Acción
    Acumed sent an Urgent Medical Device Recall letter dated March 26, 2014 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to immediately stop using and/or distributing all lots identified in the letter. Return affected products as instructed in the letter. For questions contact Acumed Business Service via email at BusinessService@acumed.net or via phone at 877-627-9957.

Device

Device Recall Acumed Tension Band Pin
  • Modelo / Serial
    50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127, 242707, 243325, 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708, 243327, 243949.  50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056.  70.0 mm Tension Band Kit: Lots 210290, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493.  90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
  • Descripción del producto
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. || 50.0 mm Tension Band Pin; Part Number 30-0097 || 70.0 mm Tension Band Pin; Part Number 30-0098 || 90.0 mm Tension Band Pin; Part Number 30-0099 || 50.0 mm Tension Band Kit; Part Number TB-1550K-S || 70.0 mm Tension Band Kit; Part Number TB-1570K-S || 90.0 mm Tension Band Kit; Part Number TB-1590K-S || Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Dirección del fabricante
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Empresa matriz del fabricante (2017)
    Acumed Llc
  • Source
    USFDA