Events

Retiro De Equipo (Recall) de Device Recall U2 Acetabular cup

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 Orthopedic Alliance 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
    64588
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1381-2013
  • Fecha de inicio del evento
    2013-02-20
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118173
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Acción
    A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Device

Device Recall U2 Acetabular cup
  • Modelo / Serial
    Item No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
  • Descripción del producto
    U2 Acetabular cup, Ti beads porous coated, ¿44mm || U2 Acetabular cup, Ti beads porous coated, ¿46mm || U2 Acetabular cup, Ti beads porous coated, ¿48mm || U2 Acetabular cup, Ti beads porous coated, ¿50mm || U2 Acetabular cup, Ti beads porous coated, ¿52mm || U2 Acetabular cup, Ti beads porous coated, ¿54mm || U2 Acetabular cup, Ti beads porous coated, ¿56mm || U2 Acetabular cup, Ti beads porous coated, ¿58mm || U2 Acetabular cup, Ti beads porous coated, ¿60mm || U2 Acetabular cup, Ti beads porous coated, ¿62mm || U2 Acetabular cup liner assembly, 10¿hooded,44mm || U2 Acetabular cup liner assembly, 10¿hooded,46mm || U2 Acetabular cup liner assembly, 10¿hooded,48mm || U2 Acetabular cup liner assembly, 10¿hooded,50mm || U2 Acetabular cup liner assembly, 10¿hooded,52mm || U2 Acetabular cup liner assembly, 10¿hooded,54mm || U2 Acetabular cup liner assembly, 10¿hooded,56mm || U2 Acetabular cup liner assembly, 10¿hooded,58mm || U2 Acetabular cup liner assembly, 10¿hooded,60mm || U2 Acetabular cup liner assembly, 10¿hooded,62mm || Variety of hip and knee implants and instruments, multiple uses.
  • Manufacturer
    Orthopedic Alliance LLC

Manufacturer

Orthopedic Alliance LLC
  • Dirección del fabricante
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA