Devices

Device Recall 3.2MM X 560MM COCR THD TIP

  • Modèle / numéro de série
    631960 668040 668020 668030 668050 668060 265460 265450 322270 354190 370190 918470 034780 101840 216280 135720 327770 363260 389080 389070 399500 436760 436770 471160 471170 005620 244600 403100 791030 791110 839790 898930 898940 898960 974090 974100 974060 974070 974080 038580 142780 142790 492260 522530 205310 767140 492270 341690 620450 118270 418780 107090 373830 600950 609070 044210 044220 612900 683640 683630 507830 675290 284100 132110 962210
  • 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
    3.2MM X 560MM COCR THD TIP; 14-441053 || 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