Devices

Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 370967 00370967N 62279438 62012576 62012576N
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 69 consists of all product under product code: JDI and same usage: || Item no: || 785301701 VERSYS CEMENTED FEM STEM || 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF || 785301601 VERSYS CEMENTED FEM STEM 16X145MM || For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

Fabricant

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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 dispositifs médicaux avec un nom similaire

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Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/8" Drain
  • Modèle / numéro de série
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Description du dispositif
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 3/16" Drain
  • Modèle / numéro de série
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Description du dispositif
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" || Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-030-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/4" Drain
  • Modèle / numéro de série
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Description du dispositif
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-040-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System Replacement Kit
  • Modèle / numéro de série
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Description du dispositif
    Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System Kit w/o Drain
  • Modèle / numéro de série
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Description du dispositif
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-060-05.
  • Manufacturer
    Zimmer Inc.
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