Events

Retiro De Equipo (Recall) de Device Recall Gemlock

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 Zimmer Dental 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
    70304
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1115-2015
  • Fecha de inicio del evento
    2015-01-22
  • Fecha de publicación del evento
    2015-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132929
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Causa
    The gemlock long hex driver may not fit into the fixture mount transfer (fmt) or the internal hex of the implant.
  • Acción
    An Urgent Device Recall Notice was sent on 1/22/15 to their domestic and foreign customers who purchased the Gemlock Long Hex Driver. The letter informs the customers of the problems identified, risks, and the actions to be taken. Customers are instructed to review the notice and check their inventory for the affected units. All affected product is to be immediately quarantined and removed from service. Customers are to contact Simmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and set up return of the products. Customers should complete the attached Business Reply Form and fax it to (574) 372-4265 or e-mail to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, Mon-Fri, 7 am-5pm (Pacific). Zimmer Dental is expanding the recall to include 1 additional lot for catalog no.TSVKIT. Zimmer Dental plans to inform an amended customer notification letter to their US and foreign consignees. The letter will go out to customers on 4/20/15 to inform them of the expanded lot.

Device

Device Recall Gemlock
  • Modelo / Serial
    Etched Lot No. 62699693 & 62735177. Lot Number on Label: 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 62743075, 62750487, 62753787, 62756920, 62759862, 62760388, 62768456, and 62773158.  Expanded Lot No. 62728173.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain
  • Descripción del producto
    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. || Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA