Events

Retiro De Equipo (Recall) de Device Recall DePuy Custom Implant Devices

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
    62766
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2217-2012
  • Fecha de inicio del evento
    2012-07-31
  • Fecha de publicación del evento
    2012-08-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111674
  • 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
    Subtalar joint-crossing uncemented semi-constrained ankle prosthesis - Product Code OOM
  • Causa
    In connection with a warning letter received from the u.S. food & drug administration on december 9, 2011, depuy orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from depuy orthopaedics, but not implanted. depuy orthopaedics received a warning letter from the fda on december 9, 2011 regarding custom device implants. depuy orthopaedics has discontinue.
  • Acción
    DePuy sent a written communication letter dated July 31, 2012 to all consignees. The communication to the hospital customers who received the devices includes a "Surgeon Letter" with instructions to provide the surgeon letter to the Surgeon users. All DePuy Distributors will be notified via email. The sales representatives notified the hospital and surgeons either by mail or in person with a written communication. The letters identified the affected product, problem and actions to be taken. Customers are instructed to complete the attached Roponse form and return to fax number 574-371-4939 or email: kseppa@its.jnj.com. The sales representatives are expected to aid customers in returning of unused Custom Device implants, if needed. The devices can be returned through the normal DePuy Returns process, to attention of "Returns" and marked "Custom Returns" on the outside of the box. Questions Regarding the Removal Questions regarding the removal may be directed to the following DePuy representatives  -Questions about removal information provided: Katie Seppa, Manager of Post-Market Surveillance, 574-372-7333 (M-F; 8 am  5 pm EDT) -Clinical related questions from surgeons: Direct to DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am-5 pm EDT)

Device

Device Recall DePuy Custom Implant Devices
  • Modelo / Serial
  • Distribución
    US Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, HI, IA, ID, IL, IN, KS, KY, LA, MA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Descripción del producto
    DePuy Custom Implant Devices || Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product || Product Usage: || Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)
  • 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