Device Recall MIS (Minimally Invasive Surgery) Toolsteel Burs

  • Modelo / Serial
    Lot Number(s):16049017 & 16053017, Product Number: 8470-009-030
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • Descripción del producto
    8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Number:16056017, Product Number: 8450-107-525
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • Descripción del producto
    8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer
  • Modelo / Serial
    Lot Number:16038017, Product Number: 8470-009-040
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • Descripción del producto
    8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer
  • Modelo / Serial
    Lot Number:16060017, Product Number: 8450-010-040
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • Descripción del producto
    8450-010-040 4.0MM Round, 13CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer
  • Modelo / Serial
    Lot Number:16032017, Product Number: 8450-009-030
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • Descripción del producto
    8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer
  • Modelo / Serial
    Lot Number:16029017, Product Number: 8450-009-040
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • Descripción del producto
    8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer