Events

Retiro De Equipo (Recall) de Device Recall PERSONA

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, 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
    70240
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1052-2015
  • Fecha de inicio del evento
    2014-12-11
  • Fecha de publicación del evento
    2015-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132621
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer - Product Code OIY
  • Causa
    Potential for delay in surgery and/or ball bearings to be left in the wound. repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. to prevent this, tasp shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
  • Acción
    Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.

Device

Device Recall PERSONA
  • Modelo / Serial
    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04: 42-5279-002-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 10mm; 42-5279-002-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 12mm; 42-5279-002-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 14mm; 42-5279-004-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 10mm; 42-5279-004-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 12mm; 42-5279-004-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 14mm; 42-5279-006-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 10mm; 42-5279-006-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 12mm; 42-5279-006-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 14mm; 42-5279-008-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 10mm; 42-5279-008-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 12mm; 42-5279-008-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 14mm; 42-5279-003-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 10mm; 42-5279-003-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 11mm; 42-5279-003-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 12mm; 42-5279-003-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 13mm; 42-5279-003-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 14mm; 42-5279-005-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 10mm; 42-5279-005-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 11mm; 42-5279-005-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 12mm; 42-5279-005-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 13mm; 42-5279-005-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 14mm; 42-5279-007-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 10mm; 42-5279-007-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 11mm; 42-5279-007-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 12mm; 42-5279-007-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 13mm; 42-5279-007-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 14mm.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA Nationwide including DC, and PR and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Dominican Republic, France, Germany, India, Iran, Israel, Italy, Japan, Luxembourg, Netherlands, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. || Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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