Devices

Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61907682 62038367 62106797 62161479 62240743 62268577 62344683 62030932 62106796 62148557 62206538 62240742 62303507 62352823
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 22 consists of all product under product code: JDI and same usage: || Item no: || 811400218 CPT 12/14 COCR REVISION S || 811400318 CPT 12/14 COCR REVISION S || 811400420 CPT 12/14 COCR REVISION S || 811400423 CPT 12/14 COCR REVISION S || 811400426 CPT 12/14 COCR REVISION S || 811400010 CPT 12/14 COCR SIZE 0 EXT || 811400000 CPT 12/14 COCR SIZE 0 STD || 811400110 CPT 12/14 COCR SIZE 1 EXT || 811400100 CPT 12/14 COCR SIZE 1 STD || 811400210 CPT 12/14 COCR SIZE 2 EXT || 811400200 CPT 12/14 COCR SIZE 2 STD || 811400230 CPT 12/14 COCR SIZE 2 XEX || 811400310 CPT 12/14 COCR SIZE 3 EXT || 811400300 CPT 12/14 COCR SIZE 3 STD || 811400330 CPT 12/14 COCR SIZE 3 XEX || 811400410 CPT 12/14 COCR SIZE 4 EXT || 811400400 CPT 12/14 COCR SIZE 4 STD || 811400430 CPT 12/14 COCR SIZE 4 XEX || 811400510 CPT 12/14 COCR SIZE 5 EXT || 811400500 CPT 12/14 COCR SIZE 5 STD || 811400530 CPT 12/14 COCR SIZE 5 XEX || For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

Fabricante

Zimmer Manufacturing B.V.
  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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

Device Recall Zimmer M/L Taper Hip Prosthesis, 7711 Series
  • Modelo / Serial
    Lot Number: 63716611; UDI: (01)00889024131736(17)270731(10)63716611
  • Clasificación del producto
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
Device Recall Zimmer M/L Taper Hip Prosthesis, 7711 Series
  • 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
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
Device Recall ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
  • 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
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
Device Recall ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
  • Modelo / Serial
    00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT
  • Clasificación del producto
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
Device Recall ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
  • 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
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
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