Device Recall Maxim

  • Modelo / Serial
    Lots 140370, 007450, 165140, 104620 and 458200.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Descripción del producto
    Biomet Maxim SI knee instruments sliding femoral 4-in-1 block 55 mm, stainless steel; Ref. RD140529.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
  • 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

151 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog No. CL60-100; Known Lot No. NHS160219.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - US including CA and VA.
  • Descripción del producto
    PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Modelo / Serial
    Catalog No. CR60-030; Lot No. Unknown.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - US including CA and VA.
  • Descripción del producto
    PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Modelo / Serial
    Catalog No. C060-050; Known Lot No. WNV110516
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - US including CA and VA.
  • Descripción del producto
    PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Modelo / Serial
    Catalog No. C060-060; Known Lot No. WNV110516
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - US including CA and VA.
  • Descripción del producto
    PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Modelo / Serial
    Catalog No. 0902-1007. Unknown Lot No.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - US including CA and VA.
  • Descripción del producto
    PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
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