Events

Retiro De Equipo (Recall) de Device Recall Flower Orthopedics Variable Angle Locking Peg

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 Flower Orthopedics Corporation.

¿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
    70578
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1314-2015
  • Fecha de inicio del evento
    2015-02-16
  • Fecha de publicación del evento
    2015-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134073
  • 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
    Locking pegs were not locking during distal radius procedures. there has been one (1) report of revision surgery scheduled to remove a loosened peg.
  • Acción
    On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.

Device

Device Recall Flower Orthopedics Variable Angle Locking Peg
  • Modelo / Serial
    All lots of Catalog Numbers:  FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
  • Descripción del producto
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. || The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
  • Manufacturer
    Flower Orthopedics Corporation

Manufacturer

Flower Orthopedics Corporation
  • Dirección del fabricante
    Flower Orthopedics Corporation, 100 Witmer Rd Ste 280, Horsham PA 19044-2647
  • Empresa matriz del fabricante (2017)
    Flower Orthopedics Corp.
  • Source
    USFDA