Device Recall 1.5x4mm HT XDrive Screw

  • Modèle / numéro de série
    Lot 148530
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.
  • Description du dispositif
    BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. || BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. || Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Société-mère du fabricant (2017)
  • 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