Device Recall Zimmer

  • Modelo / Serial
    Item numbers: 01.01012.384; 01.01012.385; 01.01012.386; 01.01012.387; 01.01012.388; 01.01012.444; 01.01012.445; 01.01012.446; 01.01012.447; 01.01012.448   Lot #'s: 2551762, 2542690, 2542691, 2543993, 2544892, 2544893, 2551930, 2551931, 2557054, 2558475, 2559787, 2563363, 2564657, 2568082, 2539887, 2540911, 2544894, 2544895, 2545830, 2545831, 2545832, 2545833, 2547043, 2547807, 2548952, 2551330, 2551860, 2551861, 2554798, 2554799, 2554800, 2558476, 2558477, 2559788, 2561617, 2562662, 2563364, 2563385, 2565407, 2566564, 2567294, 2542692, 2542693, 2544896, 2547044, 2548953, 2551932, 2553210, 2556029, 2559603, 2563386, 2539888, 2540926, 2548954, 2553419, 61487633, 61487634, 61636015, 61495961, 61495962, 61495963, 61562431, 61577697, 61608436, 61562432, 61577709, 61487635, 61562448
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Descripción del producto
    CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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

263 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    61482528, 61484443, 61495269 and 61479592.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution Nationwide, to France, and Spain.
  • Descripción del producto
    Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
  • Manufacturer
  • Modelo / Serial
    Catalog No. 00-2258-051-01; Lot No. 53951300; Manufactured 8/8/2002
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain.
  • Descripción del producto
    Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE || Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries
  • Manufacturer
  • Modelo / Serial
    Lot: 60683028, Manufactured: 6/05/2007
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.
  • Descripción del producto
    TRABECULAR METAL ¿ FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. || The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
  • Manufacturer
  • Modelo / Serial
    Lot: 60683036, Manufactured: 6/07/2007
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.
  • Descripción del producto
    TRABECULAR METAL ¿ FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32. || The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
  • Manufacturer
  • Modelo / Serial
    Item No. 42-5299-001-00 Affected Lots: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
  • Descripción del producto
    Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
  • Manufacturer
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