Biomet U.K., Ltd.

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Description

4 dispositivos en la base de datos

  • Modelo / Serial
    Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
  • Descripción del producto
    Oxford Gap Gauge SML 3/4mm. || The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
  • Modelo / Serial
    REF. 32-487557/ Lot no 2561334
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • Descripción del producto
    Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334, Biomet UK Ltd, South Wales, UK || Product Usage: Usage: Used to guide a saw blade in resecting the proximal tibia. Intended to be used with a tibial alignment guide.
  • Modelo / Serial
    REF 32-487002, Lot 2561329
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • Descripción del producto
    Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK || Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide.
  • Modelo / Serial
    REF 154600, LOT 2272736
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Outside the US to Austria, Belgium, and Germany
  • Descripción del producto
    Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) || This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

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Más información acerca de la data acá

  • Dirección del fabricante
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend South Wales United Kingdom
  • 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