Events

Retiro De Equipo (Recall) de Device Recall Phoenix Nail System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer Biomet, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79487
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1236-2018
  • Fecha de inicio del evento
    2018-03-12
  • Fecha de publicación del evento
    2018-03-27
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162454
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Certain lots of the phoenix tibia nail 3.5mm inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
  • Acción
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" notice dated 3/12/2018 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: Risk Manager: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative and quarantine all affected product. 3. Zimmer Biomet sales representative will remove the affected product from the facility. 4. Complete Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. Distributors: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Locate and quarantine affected product in your inventory. 3. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and from affected hospitals within your territory. Mark RECALL on the outside of the returned cartons. 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com EXPANSION: The firm expanded the recall to include additional lots and the new notification sent 3/23/18, also explains the additional issue that devices were etched with a supplier lot number and the packages were etched with the firm lot number. Both numbers are included in an Appendix to the notification letter.

Device

Device Recall Phoenix Nail System
  • Modelo / Serial
    Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020 508030 508070 508080 484940 485380 485410 485420 485430 485440 485450 485460 535050 623990 636950 636960 636970 636980 636990 676570 676600 676610 676620 676630 676640 928320 928340 928370 928380 090570 484120 484230 484300 484320 484330 484370 484420 484440 484450 484490 526200 526210 526230 526250 526260 526270 526280 526290 526300 598480 599230 599240 599250 599260 599270 658950 658980 658990 659000 659010 659020 676710 677010 677030 677040 697990 698710 721000 721360 721380 721390 721400 721410 721420 721440 625110 079640 508410 508450 508460 508470 508480 508490 508510 508520 508500 457030 073530 073540 073550 073560 073570 073580 073590 073600 073610 627490 656470 656580 656590 656600 656610 656620 656640 656660 966880 967050 967060 967070 980260 980270 079630 008370 008380 008390 008400 008410 091030 091060 091070 091080 980300 980320 980330 980340 980350 987180 101450 101480 111700 111760 116820 118330 142400 149540 164240 190740 201170 210470 216850 243350 268070 276080 280600 280610 302860 306510 306520 327060 327070 327310 327450 334390 335080 335090 335400 335860 336050 336590 337680 350280 395470 410060 413360 468260 491750 496810 510290 512200 527380 527390 527400 527410 527420 527430 531370 537580 537690 540340 557600 561800 573000 573010 573020 578820 579370 609980 629790 663130 665910 671300 677620 700420 783690 804170 809490 812420 812480 812490 834860 885960 916980 983220 996210 013740 031700 034530 035820 053600 079000 094440 116670 148490 232080 233850 289870 371460 384950 442070 482990 483000 523880 532610 533130 545110 571850 586840 625100 625120 662930 815370 842080 852840 861160 881130 956490 973560 983600; Laser marking on the device: 90225701 RS08A014 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90229981 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 F3L6472 F4C7912 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 F2L6299 ZB100913 ZB100913 ZB100913 ZB100913 ZB100913 ZB100913 ZB100913 ZB100913 ZB100913 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 ZB100317 90229981 ZB100317 ZB100317 90229981 90229981 F4C7912 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 90229981 ZB160502 ZB160502 ZB150702 ZB150702 ZB150702 ZB150702 ZB110501 ZB141202 ZB141202 ZB141202 ZB121001, ZB121002 ZB130902 90225701 90224951, F4C7912 ZB131201 ZB131001 ZB160101 ZB160101 ZB160702 ZB121101 ZB121101 ZB120801 ZB120802 ZB120802 ZB120802 ZB131001 ZB151101 ZB151101 ZB161002 ZB161002 ZB161001 ZB161002 ZB130902 ZB160702 ZB150703 F2L6299 F2L6299 ZB151102 ZB130901, ZB130902 ZB160501 ZB131201 ZB131201 ZB150501 ZB150501 ZB150501 ZB150501 ZB150501 ZB150501 ZB160501 ZB141001 ZB141001 ZB131001 ZB120201 ZB160701 ZB160202 ZB160202 ZB160201 ZB131201 ZB131201 ZB101201, ZB101202 F3L6472 ZB101202 ZB170201 ZB101202 ZB120701 ZB160801 ZB160801 ZB150703 ZB170203 ZB160901 ZB160901 ZB160901 ZB120802, ZB120801 90229981 ZB120201 ZB141201 ZB131001, ZB130901 ZB160502 ZB151001 3050001, 90229981 ZB151001 ZB121002, ZB121001 ZB151001 ZB120701 ZB150702 3050001 RS08C028 RS08A014, RS08A032, RS08C028, 232080 ZB101101 ZB101201 ZB110401 90227191 F3L6472 F3L6472 90227192 90227192 90227192 90227192 RS08A014 90227192 F3L6472 F3L6472 RS08A014, RS08A032  F4C7912 90227192 F4C7912 90227192 F4C7912 90227191, 90227192, 90229981, 90229021 F4C7912 90229981
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia, Brazil, Canada, Chile, Colombia, El Salvador, Netherlands, Japan, Costa Rica, Spain, and Thailand.
  • Descripción del producto
    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

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