Device Recall Zimmer

  • Modelo / Serial
    lot no: 61889853
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 9 consists of all product under HRS, and same usage: || Item no: || 47494502601 4.5 BROAD SCP PLT, 26 HOL || Product Usage: || Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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
    Lot Number: 63716611; UDI: (01)00889024131736(17)270731(10)63716611
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
  • Descripción del producto
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
  • Manufacturer
  • Modelo / Serial
    Lot Number: 63716613, UDI: (01)00889024131606(17)270731(10)63716613; Lot Number: 63716614, UDI: (01)00889024131606(17)279731(10)63716614
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
  • Descripción del producto
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
  • Manufacturer
  • Modelo / Serial
    00-5926-011-01 Knee PFJ FEM, CEMENTED, SZ 1, LEFT  00-5926-012-01 Knee PFJ FEM, CEMENTED, SZ 2, LEFT  00-5926-013-01 Knee PFJ FEM, CEMENTED, SZ 3, LEFT  00-5926-013-02 Knee PFJ FEM, CEMENTED, SZ 3, RIGHT 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT 00-5926-015-02 Knee PFJ FEM, CEMENTED, SZ 5, RIGHT
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Descripción del producto
    PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ || Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
  • Manufacturer
  • Modelo / Serial
    00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Descripción del producto
    ZIMMER PATELLA FEMORAL JOINT¿ || Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
  • Manufacturer
  • Modelo / Serial
    00-5842-012-02 61777606 00-5842-012-02 61774093 00-5842-013-01 61774095 00-5842-013-02 61777611 00-5842-014-01 11002921 00-5842-014-01 61777613 00-5842-014-02 61777615 00-5842-014-02 61777616 00-5842-015-01 61777617 00-5842-016-02 61756843
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Descripción del producto
    ZUK PRC FEM SZB RMED/LLAT¿ || ZUK PRC FEM SZC LMED/RLAT¿ || ZUK PRC FEM SZC RMED/LLAT¿ || NGU PRC FEM SZD LMED/RLAT¿ || ZUK PRC FEM SZD RMED/LLAT¿ || ZUK PRC FEM SZE LMED/RLAT || ZUK PRC FEM SZF RMED/LLAT || " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
  • Manufacturer
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