Devices

Device Recall JUGGERKNOT

  • Modèle / numéro de série
    Part number: 912050 Lot number: 221890
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US in the state of Texas
  • Description du dispositif
    JUGGERKNOT 2.9MM 2 #2 MB || Product Usage: || For use in hip arthroplasty
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Fabricant

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

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Device Recall Juggerknot Soft Anchors
  • Modèle / numéro de série
    Lot #: M050020, Ml02470, M205970, M206170, M335840, M451670, M554290, M592790, M906510, M050030, M102480, M205980, M206180, M335860, M451680, M554300, M596210, M906540, M050040, M102490, M205990, M206200, M335870, M451690, M554310, M666350, M906550, M050050, M102500, M206000, M213400, M336170, M451700, M555140, M666360, M974690, M050060, M102510, M206010, M213410, M350540, M475050, M571420, M725330, M974720, M050070, M102520, M206030, M213420, M350550, M479960, M571560, M725340, M050080, M102530, M206060, M248050, M350560, M506760, M571570, M727850, M051940, M102540, M206070, M248060, M350570, M513940, M571580, M762160, M051950, M185150, M206080, M248070, M351000, M537410, M571600, M802400, M051960, M185160, M206090, M248080, M354670, M554260, M571730, M802410, M051970, M205940, M206140, M248090, M451650, M554270, M571760, M802420, M072920, M205960, M206150, M248100, M451660, M554280, M571800, and M860160
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.
  • Description du dispositif
    REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. || Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
  • Manufacturer
    Biomet, Inc.