Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61932449 62126613 62204611 62213348 62406239 62203954 62204587 62332733 62236654 62406245
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 34 consists of all product under product code: JWH and same usage: || Item no: || 522001700 I/B II KNEE DOMED PATELLA || 522001800 I/B II KNEE DOMED PATELLA || 522001900 I/B II KNEE DOMED PATELLA || for use in total knee arthroplasty
  • 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
    BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01;  Expiration dates 5/8/14-12/31/15
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution in states of: AZ, CO, IL, OR, and WA.
  • Descripción del producto
    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer || The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
  • Manufacturer
  • Modelo / Serial
    Lot 2385941.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Maryland.
  • Descripción del producto
    Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
  • Manufacturer
  • Modelo / Serial
    Lot No: 60646894.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • Modelo / Serial
    Lot No: 60651168 and 60726506.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Descripción del producto
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
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