Events

Retiro De Equipo (Recall) de Device Recall Sterile Distraction Screws of 3 different sizes

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 Tedan Surgical Innovations 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
    62899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2385-2012
  • Fecha de inicio del evento
    2012-06-11
  • Fecha de publicación del evento
    2012-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112010
  • 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
    This letter is to notify you that several of our sterile screw products are being voluntarily recalled. product sterility may be compromised due to a mechanical failure of the protective packaging tube. tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
  • Acción
    The firm, TeDan Surgical Innovations (TSI), sent an "URGENT: Medical Device Recall" letter dated June 11, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine all products subject to recall and return product to TSI. In addition, if they have further distributed this product, identify all customers and notify them of this product recall at once in writing; and complete and return the enclosed Mandatory Response Form as soon as possible and no later than June 25, 2012 via mail: 12675 W. Airport Blvd., Suite 200, Sugar Land, TX 77478; fax: (713) 726-0846 or email: thernandez@tedansurgical.com. If you have any questions, contact the Business Manager at 713-726-0886, Monday thru Friday, from 8am - 5pm or via email at THERNANDEZ@TEDANSURGICAL.COM.

Device

Device Recall Sterile Distraction Screws of 3 different sizes
  • Modelo / Serial
    Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782,  021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
  • Descripción del producto
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand || Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
  • Manufacturer
    Tedan Surgical Innovations Llc

Manufacturer

Tedan Surgical Innovations Llc
  • Dirección del fabricante
    Tedan Surgical Innovations Llc, 12615 W Airport Blvd, Ste 200, Sugar Land TX 77478-6203
  • Empresa matriz del fabricante (2017)
    Tedan Surgical Innovations L.L.C.
  • Source
    USFDA