Events

Retiro De Equipo (Recall) de Device Recall RECLAIM DISTAL TAPERED

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 DePuy Orthopaedics, 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
    68440
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2082-2014
  • Fecha de inicio del evento
    2014-06-03
  • Fecha de publicación del evento
    2014-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127714
  • 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, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
  • Causa
    The product can be difficult to remove from the distal stem both out of the package and after proximal reaming.
  • Acción
    DePuy Synthes sent an Urgent Information - Device Correction Notice letter dated June 24, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: 1. Immediate Remedy: Discard the RECLAIM¿ Taper Sleeve Protector instrument before stem implantation. 2. Changes to the literature and IFU: Documents are revised as follows: " RECLAIM¿ Revision Hip Systems Surgical Technique # DSUS/JRC/0614/0200  pages 11, 12, 13, 16, 30, 34, 35 (figure numbering from pages 11 to 27 were also revised): Removed information regarding taper sleeve protector. " RECLAIM¿ Revision Hip Systems Surgical Technique FAQ # DSUS/JRC/0614/0202  pages 1 and 2: Removed information regarding taper sleeve protector. " RECLAIM¿ Revision Hip Systems IFU #090200799 REV E  Page 5: Verbiage will be revised and implemented as soon as possible, depending on regulatory approvals. 3. Change: The company consulted with design surgeons and developed a strategy to eliminate the taper sleeve protector from the system. As a result of removing the taper sleeve protector, the company is evaluating whether there is a need for a protective component to be used during the distribution Customers with questions were instructed to call 574-371-4917. For questions regarding this recall call 574-371-4577.

Device

Device Recall RECLAIM DISTAL TAPERED
  • Modelo / Serial
    Product # 297500110 Lot # 126559; 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.
  • Descripción del producto
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA