Events

Retiro De Equipo (Recall) de Device Recall Integra 2.7 mm Drilling Guide

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 Integra Life Sci..

¿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
    62728
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2381-2012
  • Fecha de inicio del evento
    2012-06-14
  • Fecha de publicación del evento
    2012-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111515
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Causa
    Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. none of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure. a physician was consulted to assess patient risk and concluded that any potential for risk would be transient, self-limiting or minor, or result.
  • Acción
    Integra sent a "SUBJECT: MEDICAL DEVICE RECALL" letter dated June 14, 2012 to all affected customers. The letter identified the product, problem, and action to be taken by the customers. Customers were asked to complete a Recall Acknowledgement and Return Form whether or not they were affected by the recall, and return all their affected inventory to Integra LifeSciences. Customers were asked to contact their regional managers or the firm at 609-936-6832 for questions regarding the recall.

Device

Device Recall Integra 2.7 mm Drilling Guide
  • Modelo / Serial
    The Lot No's for the affected 2.7mm Drilling Guides are: E1DT, E4EX, E57T, E5YA, E64W, E6GN, E6RB, E6WP, E7UL, E86B, E8UC, E9PX, E9Q5, E9QD, EBNY, EEYJ, EF11, EFCM, EGT6, EH6X, EHL2, EJB3, EJZE, EKJ4, EKN4, EKZV, EKZW, EL3G, EL3X, ELH8, EMCQ, EMCX, EN19, ENR9, ENRA, ENS0, EPTL, and EPTQ
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, Czech republic, Denmark, France, Germany, Ireland, Israel, Italy, Kingdom of Saudi Arabia, Lebanon, Norway, Portugal, Switzerland, South Africa, Spain, Sweden, and United Kingdom.
  • Descripción del producto
    The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. || The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. || Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint
  • Manufacturer
    Integra Life Sci.

Manufacturer

Integra Life Sci.