Events

Retiro De Equipo (Recall) de Stryker

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 Stryker Howmedica Osteonics Corp..

¿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
    75015
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2789-2016
  • Fecha de inicio del evento
    2016-08-01
  • Fecha de publicación del evento
    2016-09-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149119
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    Upon failure of the press-fit, the clamping sub components and pins could disassociate from the scorpio patella assembly instrument.
  • Acción
    Stryker sent an "Urgent Medical Device Recall Notification" Letter and Recall Business Reply Form dated August 1, 2016 to their affected customers via email and also via UPS on August 1, 2016. Customers are asked to quarantine the product subject to this recall. Branches/Agencies are asked to return all affected products available at their location to: Stryker C/O Stericycle, Attn: RA 2016-098 - Event 8296. Hospital/Branches: Customers are asked to complete and sign the Business Reply Form and fax a copy within 5 business days to: 877-272-6141 or email to Stericycle strykerortho8296@stericycle.com. Any questions, customers can call (201) 831-6693.

Device

Stryker
  • Modelo / Serial
    Catalog No. 3182-1000 Lot #'s: RD8E100, RD8A054TT, RD8A054T, RD8E099M, RD8E099A, RD8E099, RD8A054A, RD8E099D, RD8A053A, RD8A054, RD8A053T, RD7K062L, RD8A052A, RD8A052E, RD8A052, RD8A053, RD7E128D, RD5T290H, RD7E128T, RD5S262D, RD5T290W, RD7K062E, RD5S262X, RD7E128Y, RD7A076MA, RD6W102MA, RD7K062A, RD7K062, RD7E128H, RD7A076A, RD7E128A, RS7E128, RD6W103D, RD6V108J, RD6V108K, RD6V108H, RD7A076H, RD6V112M, RD7A074D, RD7A076J, RD6V112H, RD6W102m, RD5H286A, RD2V022, RD2K049, RD6W103, RD5H286J, RD2T037A, RD7A076M, RD6S136A, RD5H286, RD2V031C, RD5N361T, RD6V112A, RD4M068J, RD2V021C, RD7A076, RD6V112, RD4E226W, RD2V021, RD7A074H, RD6W102, RD4S220W, RD2V023X2, RD6W103A, RD6S136M, RD4M069D, RD2V023X3, RD6V108, RD5W148M, RD4S220, RD2V023, RD7A074, RD5M237K, RD4S220A, RD2V031A, RD7A074A, RD5T290X, RD4S220A1, RD2V023X1, RD6W103M, RD5T290A, RD4M069, RD2V031, RD5K116A, RD6S137A, RD4L128X1, RD2V031X2, RD5M236T, RD5W148A, RD4L128V, RD2V031X1, RD5K116T, RD6S137, RD4E226J, RD2N030K, RD3V002A, RD6S136, RD4M068< RD2T037, RD5M237, RD5W148X, RD4L128, RD2T037X, RD5K116N, RD5W148, RD4E226M, RD2N030E, RD5K116, RD5T290M, RD4E226L1, RD2N030S, RD5M236, RD5T290E, RD4C230L, RD2N030X, RD5H286L, RD5T290, RD4E226L, RD2N030XX, RD3T155L, RD5T290D, RD4E226, RD2N030, RD2V021E, RD5N361A, RD4C162L, RD2K068W, RD2V022W, RD5S305J, RD4C162, RD2N030X1, RD2V021S, RD5S305M, RD4C230, RD2M019E, RD2V022K, RD5N361M, RD4C230X, RD2M039, RD2V022E, RD5S305, RD3V002P, RD2M019H, RD2V021H, RD5S262A, RD3V002X1, RD2K049H, RD2V023E, RD5S262M1, RD3V002X2, RD2M003H, RD2T037W, RD5S262M, RD3V002D1, RD2M038H, RD2K068X1, RD5S262J, RD3V002, RD2K068B, RD2K068, RD5S262, RD3V002D, RD2M003, RD2K049R, RD5N361H, RD3V206D, RD2M038, RD2K049E, RD5M259M, RD3T160L1, RD2M019, RD2K017E, RD5N316, RD3V206X1, RD2K068S, RD2H056, RD5H286D, RD3T155L1, RD2K056S, RD2K056, RD5M259T, RD3T160L3, RD2K065S, RD2K065, RD5M236H, RD3T160, RD2K049S, RD2K017, RD5M259, RD3T160L2, RD2K068E, RD5M237L, RD3T160L, RD2H056E, RD5K116J, RD3V206, RD2K065E, RD4S220D, RD3T155 and RD2K056E
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide and Internationally
  • Descripción del producto
    Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) || The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA