Events

Retiro De Equipo (Recall) de Device Recall MANOS EX

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 Thayer Intellectual Property, 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
    75630
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0702-2017
  • Fecha de inicio del evento
    2016-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150962
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    The firm failed to notify current customers of ifu update/warning. during a recent fda inspection, it was discovered that thayer intellectual property, inc. had revised their ifu to include a warning not to bend, deform or otherwise modify any part of the device. the warning was added as a result of a maude report filed in december 2014 where a piece of the manos ex broke during use and was left in the patient's hand. the patient suffered a tendon injury and an additional surgery was required to remove the broken piece of the device and repair the tendon. fda inspection found that while the firm had updated their ifu, they had not notified customers who had been shipped the device with the older version that did not include the warning. risk: it is important for manos ex users to be aware that bending, deforming, or modifying the device could result in device breakage which could impact patient safety and device performance.
  • Acción
    Thayer sent an Urgent Medical Device Correction letters dated November 4, 2016 by Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were asked to check if any of the affected lots were still available, and if so, to change out the IFU with version 5. For questions call 415-923-9375.

Device

Device Recall MANOS EX
  • Modelo / Serial
    LOT 1055337, Expiry 4/01/2015; LOT 1071800. Expiry 5/1/2017; LOT 1102580; Expiry 8/1/2017; LOT 1154179; Expiry 12/01/2017.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID, SD, IN, and GA.
  • Descripción del producto
    MANOS EX (CAT#TY-12-101) || Product Usage: || Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.
  • Manufacturer
    Thayer Intellectual Property, Inc.

Manufacturer

Thayer Intellectual Property, Inc.
  • Dirección del fabricante
    Thayer Intellectual Property, Inc., 1331 N California Blvd Ste 320, Walnut Creek CA 94596-4563
  • Empresa matriz del fabricante (2017)
    Thayer Intellectual Property Inc.
  • Source
    USFDA