Devices

Device Recall BALL TIP GUIDE WIRE 3.2MMX98CM

  • Modelo / Serial
    206660 230706 336160 361630 233262 448180 239047 700990 726170 828140 251680 828150 828100 932260 991350 991420 257058 152610 244850 244840 579040 579060 607290 662730 266560 746130 891170 832130 945420 275658 277507 083000 283676 473260 473270 769460 769470 809470 855610 466680 466700 466690 870170 983590 983770 983780 983600 342490 342560 342580 342590 342600 342610 342620 351370 351360 714680 422590 422610 422640 639830 741180 916630 934020 181790 462670 492510 492520 579490 929360 152000 362310 266540 687720 383870 384390 400980 824370 316600 316610 316630 316620 056630 056640 241130 241120 433960 838690 284980 284990 284960 720780 031840 220850 233970 291970 891450 891460 978430 159640 224200 515930 643890 907460 520050 141150 401760 495360 895470 223120 858380 822490 822500 822510 080760 108480 274700 773730 931830 683150 391810 391820 391830 370500 599560 120420 120430 175580 695660 399290 399300 692960 172710 172730 929090 963120 963130
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
  • Descripción del producto
    BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 || 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

Fabricante

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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