Devices

Device Recall BALL TIP GUIDE WIRE 3.2MMX55CM

  • Modèle / numéro de série
    410640 410650 413650 561810 700980 828080 843730 244860 579030 265412 276373 562990 754210 235170 546830 579480 929310 013900 958060 560420 560450 C32280 C32290 E36750 056530 241100 089550 528280 015770 564990 643870 067590 822470 822480 670840 038710 391720 380280 558070 016760 174930 695650 399280 932230 963110
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
  • Description du dispositif
    BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 || Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
  • 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