Retiro De Equipo (Recall) de Device Recall Reprocessed Xcel Bladeless Trocar (H12LP)

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 Stryker Sustainability Solutions.

¿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
    75675
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0765-2017
  • Fecha de inicio del evento
    2016-11-11
  • Fecha de publicación del evento
    2016-12-14
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-05-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
  • Causa
    An increase in reports indicating that the reprocessed h12lp trocar adjustable plug may break in the packaging or during use.
  • Acción
    Stryker sent an Urgent Medical Device Recall letter to all affected customers on November 11, 2016. Customers were instructed to discontinue use of the affected lots and were asked to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices from the lots referenced in Attachment 1 remain in their inventory. This form must be completed even if no affected product is found. www.novasyte.com/sss142 Use the following reference number as you complete the form: [Ship to Account #]. If the form indicates that any affected devices remain in your inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to your facility. Address any questions regarding the recall to Novasyte by calling (760) 279-3180 or emailing sss142@novasyte.com.

Device

  • Modelo / Serial
    Model Lot Manufacture Date Expiration H12LP 3 5 3 6 585 3/3/2015 Mar-18 H12LP 3 5 3 6 880 3/3/2015 Mar-18 H12LP 3 5 3 9 579 3/3/2015 Mar-18 H12LP 3 5 4 0 175 3/5/2015 Mar-18 H12LP 3 5 4 2 016 3/5/2015 Mar-18 H12LP 3 5 4 3 606 3/5/2015 Mar-18 H12LP 3 5 4 3 610 3/9/2015 Mar-18 H12LP 3 5 4 6 115 3/9/2015 Mar-18 H12LP 3 5 4 6 751 3/9/2015 Mar-18 H12LP 3 5 4 6 767 3/9/2015 Mar-18 H12LP 3 5 4 8 518 3/11/2015 Mar-18 H12LP 3 5 4 8 368 3/13/2015 Mar-18 H12LP 3 5 4 9 294 3/13/2015 Mar-18 H12LP 3 5 4 9 583 3/13/2015 Mar-18 H12LP 3 5 5 7 373 3/16/2015 Mar-18 H12LP 3 5 5 9 424 3/16/2015 Mar-18 H12LP 3 5 5 9 453 3/16/2015 Mar-18 H12LP 3 5 6 0 044 3/16/2015 Mar-18 H12LP 3 5 6 0 160 3/16/2015 Mar-18 H12LP 3 5 6 1 254 3/16/2015 Mar-18 H12LP 3 5 6 1 368 3/16/2015 Mar-18 H12LP 3 5 6 1 797 3/16/2015 Mar-18 H12LP 3 5 6 2 147 3/16/2015 Mar-18 H12LP 3 5 6 2 759 3/16/2015 Mar-18 H12LP 3 5 6 2 771 3/16/2015 Mar-18 H12LP 3 5 6 4 013 3/16/2015 Mar-18 H12LP 3 5 6 7 588 3/20/2015 Mar-18 H12LP 3 5 6 9 977 3/20/2015 Mar-18 H12LP 3 5 7 2 483 3/20/2015 Mar-18 H12LP 3 5 7 3 055 3/20/2015 Mar-18 H12LP 3 5 7 4 237 3/23/2015 Mar-18 H12LP 3 5 7 4 758 3/23/2015 Mar-18 H12LP 3 5 7 6 241 3/26/2015 Mar-18 H12LP 3 5 7 6 256 3/26/2015 Mar-18 H12LP 3 5 7 8 827 3/26/2015 Mar-18 H12LP 3 5 7 9 519 3/27/2015 Mar-18 H12LP 3 5 8 1 796 3/27/2015 Mar-18 H12LP 3 5 8 4 936 3/27/2015 Mar-18 H12LP 3 5 8 5 050 3/27/2015 Mar-18 H12LP 3 5 8 5 045 3/31/2015 Mar-18 H12LP 3 5 9 0 552 3/31/2015 Mar-18 H12LP 3 5 9 1 204 3/31/2015 Mar-18 H12LP 3 5 9 5 638 4/6/2015 Apr-18 H12LP 3 6 0 0 132 4/6/2015 Apr-18 H12LP 3 5 9 5 640 4/9/2015 Apr-18 H12LP 3 5 9 8 881 4/9/2015 Apr-18 H12LP 3 6 0 0 653 4/9/2015 Apr-18 H12LP 3 6 1 8 260 4/23/2015 Apr-18 H12LP 3 6 0 0 885 4/28/2015 Apr-18 H12LP 3 6 0 1 108 4/28/2015 Apr-18 H12LP 3 6 2 7 407 4/28/2015 Apr-18 H12LP 3 6 0 0 956 4/29/2015 Apr-18 H12LP 3 6 1 8 738 5/4/2015 May-18 H12LP 3 6 1 8 740 5/4/2015 May-18 H12LP 3 6 2 1 258 5/4/2015 May-18 H12LP 3 6 2 1 270 5/4/2015 May-18 H12LP 3 6 2 1 465 5/4/2015 May-18 H12LP 3 6 2 2 983 5/4/2015 May-18 H12LP 3 6 2 3 066 5/4/2015 May-18 H12LP 3 6 2 5 266 5/4/2015 May-18 H12LP 3 6 2 5 278 5/4/2015 May-18 H12LP 3 6 2 6 334 5/4/2015 May-18 H12LP 3 6 2 6 368 5/4/2015 May-18 H12LP 3 6 2 6 967 5/4/2015 May-18 H12LP 3 6 2 9 293 5/4/2015 May-18 H12LP 3 6 3 0 383 5/4/2015 May-18 H12LP 3 6 2 7 257 5/6/2015 May-18 H12LP 3 6 2 7 411 5/6/2015 May-18 H12LP 3 6 3 0 752 5/6/2015 May-18 H12LP 3 6 3 0 768 5/6/2015 May-18 H12LP 3 6 3 2 514 5/6/2015 May-18 H12LP 3 6 3 3 784 5/6/2015 May-18 H12LP 3 6 3 1 516 5/8/2015 May-18 H12LP 3 6 3 3 922 5/8/2015 May-18 H12LP 3 6 4 2 785 5/8/2015 May-18 H12LP 3 6 4 2 841 5/8/2015 May-18 H12LP 3 6 4 2 650 5/11/2015 May-18 H12LP 3 6 4 3 660 5/11/2015 May-18 H12LP 3 6 4 3 694 5/11/2015 May-18 H12LP 3 6 4 4 701 5/11/2015 May-18 H12LP 3 6 4 6 364 5/11/2015 May-18 H12LP 3 6 4 7 952 5/11/2015 May-18 H12LP 3 6 4 7 968 5/11/2015 May-18 H12LP 3 6 4 8 893 5/11/2015 May-18 H12LP 3 6 4 8 903 5/11/2015 May-18 H12LP 3 6 3 3 933 5/13/2015 May-18 H12LP 3 6 5 1 572 5/13/2015 May-18 H12LP 3 6 5 1 586 5/13/2015 May-18 H12LP 3 6 4 4 729 5/15/2015 May-18 H12LP 3 6 5 4 744 5/15/2015 May-18 H12LP 3 6 5 5 084 5/15/2015 May-18 H12LP 3 6 5 5 097 5/15/2015 May-18 H12LP 3 6 5 6 718 5/15/2015 May-18 H12LP 3 6 5 6 725 5/15/2015 May-18 H12LP 3 6 6 0 049 5/18/2015 May-18 H12LP 3 6 6 2 085 5/18/2015 May-18 H12LP 3 5 9 1 178 5/21/2015 May-18 H12LP 3 5 9 4 312 5/21/2015 May-18 H12LP 3 6 6 2 403 5/21/2015 May-18 H12LP 3 6 6 9 729 5/22/2015 May-18 H12LP 3 6 7 7 361 5/22/2015 May-18 H12LP 3 6 7 8 137 5/22/2015 May-18 H12LP 3 6 7 8 171 5/22/2015 May-18 H12LP 3 6 7 9 918 5/22/2015 May-18 H12LP 3 6 7 9 939 5/27/2015 May-18 H12LP 3 6 8 0 287 5/27/2015 May-18 H12LP 3 6 8 0 959 5/27/2015 May-18 H12LP 3 6 7 2 428 5/28/2015 May-18 H12LP 3 6 8 0 577 5/28/2015 May-18 H12LP 3 6 9 2 959 6/1/2015 Jun-18 H12LP 3 6 9 8 936 6/4/2015 Jun-18 H12LP 3 6 9 8 943 6/4/2015 Jun-18 H12LP 3 7 0 3 025 6/4/2015 Jun-18 H12LP 3 7 0 7 017 6/4/2015 Jun-18 H12LP 3 7 0 8 496 6/5/2015 Jun-18 H12LP 3 7 0 8 546 6/5/2015 Jun-18 H12LP 3 7 1 0 388 6/5/2015 Jun-18 H12LP 3 7 1 0 498 6/5/2015 Jun-18 H12LP 3 7 1 1 263 6/5/2015 Jun-18 H12LP 3 7 1 2 572 6/5/2015 Jun-18 H12LP 3 7 1 2 909 6/5/2015 Jun-18 H12LP 3 7 1 2 913 6/9/2015 Jun-18 H12LP 3 7 1 3 407 6/9/2015 Jun-18 H12LP 3 7 1 3 901 6/9/2015 Jun-18 H12LP 3 7 1 4 983 6/9/2015 Jun-18 H12LP 3 7 1 5 570 6/9/2015 Jun-18 H12LP 3 7 1 5 589 6/9/2015 Jun-18 H12LP 3 7 1 6 638 6/9/2015 Jun-18 H12LP 3 7 1 5 074 6/11/2015 Jun-18 H12LP 3 7 1 7 973 6/11/2015 Jun-18 H12LP 3 7 1 9 225 6/11/2015 Jun-18 H12LP 3 7 2 0 057 6/11/2015 Jun-18 H12LP 3 7 2 2 329 6/15/2015 Jun-18 H12LP 3 7 2 5 181 6/15/2015 Jun-18 H12LP 3 7 2 6 772 6/15/2015 Jun-18 H12LP 3 7 2 7 435 6/15/2015 Jun-18 H12LP 3 7 3 0 715 6/17/2015 Jun-18 H12LP 3 7 3 1 099 6/17/2015 Jun-18 H12LP 3 7 3 2 833 6/17/2015 Jun-18 H12LP 3 7 3 2 851 6/17/2015 Jun-18 H12LP 3 7 3 2 898 6/17/2015 Jun-18 H12LP 3 7 3 7 917 6/19/2015 Jun-18 H12LP 3 7 4 1 225 6/22/2015 Jun-18 H12LP 3 7 4 1 256 6/22/2015 Jun-18 H12LP 3 7 4 2 041 6/22/2015 Jun-18 H12LP 3 7 4 4 436 6/22/2015 Jun-18 H12LP 3 7 4 6 004 6/22/2015 Jun-18 H12LP 3 7 4 8 349 6/24/2015 Jun-18 H12LP 3 7 5 1 993 6/29/2015 Jun-18 H12LP 3 7 5 2 003 6/29/2015 Jun-18 H12LP 3 7 5 8 494 6/29/2015 Jun-18 H12LP 3 7 5 9 302 6/29/2015 Jun-18 H12LP 3 7 5 9 534 6/29/2015 Jun-18 H12LP 3 7 6 0 136 6/30/2015 Jun-18 H12LP 3 7 6 2 495 6/30/2015 Jun-18 H12LP 3 7 6 2 972 6/30/2015 Jun-18 H12LP 3 7 6 5 649 6/30/2015 Jun-18 H12LP 3 7 6 8 045 7/6/2015 Jul-18 H12LP 3 7 6 9 980 7/6/2015 Jul-18 H12LP 3 7 7 1 161 7/6/2015 Jul-18 H12LP 3 7 7 5 668 7/8/2015 Jul-18 H12LP 3 7 7 5 681 7/8/2015 Jul-18 H12LP 3 7 7 9 516 7/8/2015 Jul-18 H12LP 3 7 8 3 776 7/10/2015 Jul-18 H12LP 3 7 8 6 146 7/10/2015 Jul-18 H12LP 3 7 8 6 957 7/10/2015 Jul-18 H12LP 3 7 7 8 024 7/13/2015 Jul-18 H12LP 3 7 8 2 202 7/13/2015 Jul-18 H12LP 3 7 8 4 430 7/13/2015 Jul-18 H12LP 3 7 9 2 212 7/15/2015 Jul-18 H12LP 3 7 9 4 403 7/15/2015 Jul-18 H12LP 3 7 9 4 419 7/15/2015 Jul-18 H12LP 3 7 9 9 917 7/16/2015 Jul-18 H12LP 3 7 9 9 929 7/16/2015 Jul-18 H12LP 3 8 0 0 013 7/16/2015 Jul-18 H12LP 3 8 0 3 761 7/20/2015 Jul-18 H12LP 3 8 0 3 918 7/20/2015 Jul-18 H12LP 3 8 0 4 868 7/20/2015 Jul-18 H12LP 3 8 0 7 840 7/22/2015 Jul-18 H12LP 3 8 0 9 891 7/22/2015 Jul-18 H12LP 3 8 1 0 037 7/22/2015 Jul-18 H12LP 3 8 1 0 783 7/22/2015 Jul-18 H12LP 3 8 1 0 806 7/22/2015 Jul-18 H12LP 3 8 1 1 525 7/23/2015 Jul-18 H12LP 3 8 1 1 778 7/23/2015 Jul-18 H12LP 3 8 1 3 019 7/23/2015 Jul-18 H12LP 3 8 1 3 042 7/23/2015 Jul-18 H12LP 3 8 1 5 917 7/28/2015 Jul-18 H12LP 3 8 1 6 258 7/28/2015 Jul-18 H12LP 3 8 1 7 655 7/29/2015 Jul-18 H12LP 3 8 2 0 257 7/29/2015 Jul-18 H12LP 3 8 2 1 740 7/29/2015 Jul-18 H12LP 3 8 1 8 770 7/30/2015 Jul-18 H12LP 3 8 2 2 395 7/30/2015 Jul-18 H12LP 3 8 2 3 167 7/30/2015 Jul-18 H12LP 3 8 2 8 192 7/30/2015 Jul-18 H12LP 3 8 2 8 222 7/30/2015 Jul-18 H12LP 3 8 3 0 778 7/30/2015 Jul-18 H12LP 3 8 2 9 338 8/5/2015 Aug-18 H12LP 3 8 3 1 629 8/5/2015 Aug-18 H12LP 3 8 3 3 206 8/7/2015 Aug-18 H12LP 3 8 3 4 196 8/7/2015 Aug-18 H12LP 3 8 3 4 203 8/7/2015 Aug-18 H12LP 3 8 4 1 494 8/10/2015 Aug-18 H12LP 3 8 4 3 375 8/10/2015 Aug-18 H12LP 3 8 4 6 698 8/10/2015 Aug-18 H12LP 3 8 4 5 650 8/12/2015 Aug-18 H12LP 3 8 4 8 891 8/12/2015 Aug-18 H12LP 3 8 4 9 655 8/12/2015 Aug-18 H12LP 3 8 5 2 513 8/12/2015 Aug-18 H12LP 3 8 5 3 141 8/17/2015 Aug-18 H12LP 3 8 5 4 774 8/17/2015 Aug-18 H12LP 3 8 6 1 804 8/19/2015 Aug-18 H12LP 3 8 6 3 303 8/21/2015 Aug-18 H12LP 3 8 6 4 693 8/21/2015 Aug-18 H12LP 3 8 7 0 240 8/24/2015 Aug-18 H12LP 3 8 6 6 398 8/26/2015 Aug-18 H12LP 3 8 7 3 578 8/26/2015 Aug-18 H12LP 3 8 7 9 078 8/26/2015 Aug-18 H12LP 3 8 8 1 364 8/26/2015 Aug-18 H12LP 3 8 8 6 277 8/26/2015 Aug-18 H12LP 3 8 8 0 942 8/28/2015 Aug-18 H12LP 3 8 9 0 070 8/28/2015 Aug-18 H12LP 3 8 9 0 089 8/28/2015 Aug-18 H12LP 3 8 9 1 092 8/28/2015 Aug-18 H12LP 3 8 9 4 286 8/31/2015 Aug-18 H12LP 3 8 9 4 678 8/31/2015 Aug-18 H12LP 3 8 9 6 022 8/31/2015 Aug-18 H12LP 3 8 9 7 381 8/31/2015 Aug-18 H12LP 3 9 0 1 817 9/2/2015 Sep-18 H12LP 3 9 1 9 589 9/10/2015 Sep-18 H12LP 3 9 2 3 533 9/10/2015 Sep-18 H12LP 4 0 7 0 594 11/2/2015 Nov-18 H12LP 4 0 7 1 923 11/2/2015 Nov-18 H12LP 4 0 8 6 802 11/6/2015 Nov-18 H12LP 4 1 0 8 634 11/16/2015 Nov-18 H12LP 4 1 0 9 934 11/16/2015 Nov-18 H12LP 4 1 1 3 667 11/20/2015 Nov-18 H12LP 4 1 1 8 604 11/20/2015 Nov-18 H12LP 4 1 1 7 718 11/25/2015 Nov-18 H12LP 4 1 3 3 825 11/25/2015 Nov-18 H12LP 4 1 3 8 769 11/25/2015 Nov-18 H12LP 4 1 4 7 801 11/30/2015 Nov-18 H12LP 3 8 4 9 330 12/3/2015 Dec-18 H12LP 4 1 5 4 685 12/4/2015 Dec-18 H12LP 4 1 5 8 429 12/4/2015 Dec-18 H12LP 4 1 7 0 275 12/9/2015 Dec-18 H12LP 4 1 7 3 170 12/9/2015 Dec-18 H12LP 4 1 7 8 006 12/9/2015 Dec-18 H12LP 4 1 7 9 279 12/9/2015 Dec-18 H12LP 4 1 8 7 693 12/11/2015 Dec-18 H12LP 4 1 9 8 853 12/16/2015 Dec-18 H12LP 4 2 0 2 332 12/16/2015 Dec-18 H12LP 4 2 3 5 633 1/5/2016 Jan-19 H12LP 4 2 4 5 630 1/8/2016 Jan-19 H12LP 4 2 7 4 018 1/18/2016 Jan-19 H12LP 4 2 8 2 444 1/22/2016 Jan-19 H12LP 4 3 8 6 368 3/3/2016 Mar-19 H12LP 4 4 0 1 698 3/9/2016 Mar-19 H12LP 4 5 1 2 285 4/29/2016 Apr-19 H12LP 4 5 1 3 266 4/29/2016 Apr-19 H12LP 4 5 1 5 596 5/2/2016 May-19 H12LP 4 5 1 8 648 5/2/2016 May-19 H12LP 4 5 1 8 607 5/4/2016 May-19 H12LP 4 5 2 4 457 5/4/2016 May-19 H12LP 4 5 2 8 655 5/6/2016 May-19 H12LP 4 5 2 9 566 5/6/2016 May-19 H12LP 4 5 3 0 457 5/6/2016 May-19 H12LP 4 5 3 1 659 5/6/2016 May-19 H12LP 4 5 3 3 116 5/6/2016 May-19 H12LP 4 5 3 9 867 5/9/2016 May-19 H12LP 4 5 4 1 625 5/11/2016 May-19 H12LP 4 5 4 5 105 5/11/2016 May-19 H12LP 4 5 4 5 612 5/11/2016 May-19 H12LP 4 5 4 5 198 5/13/2016 May-19 H12LP 4 5 4 8 729 5/13/2016 May-19 H12LP 4 5 4 8 738 5/13/2016 May-19 H12LP 4 5 5 1 779 5/13/2016 May-19 H12LP 4 5 5 1 780 5/13/2016 May-19 H12LP 4 5 5 7 026 5/16/2016 May-19 H12LP 4 5 6 1 287 5/18/2016 May-19 H12LP 4 5 6 2 934 5/18/2016 May-19 H12LP 4 4 5 8 288 5/20/2016 May-19 H12LP 4 4 5 9 232 5/20/2016 May-19 H12LP 4 4 6 0 302 5/20/2016 May-19 H12LP 4 4 6 6 103 5/20/2016 May-19 H12LP 4 4 6 6 644 5/20/2016 May-19 H12LP 4 4 6 7 337 5/20/2016 May-19 H12LP 4 4 6 9 802 5/20/2016 May-19 H12LP 4 4 7 0 971 5/20/2016 May-19 H12LP 4 4 7 3 956 5/20/2016 May-19 H12LP 4 4 7 3 960 5/20/2016 May-19 H12LP 4 4 7 4 932 5/20/2016 May-19 H12LP 4 4 7 4 945 5/20/2016 May-19 H12LP 4 4 7 6 349 5/20/2016 May-19 H12LP 4 4 7 7 829 5/20/2016 May-19 H12LP 4 4 7 9 578 5/20/2016 May-19 H12LP 4 5 6 6 912 5/20/2016 May-19 H12LP 4 5 6 7 856 5/20/2016 May-19 H12LP 4 5 7 2 487 5/23/2016 May-19 H12LP 4 5 7 4 907 5/23/2016 May-19 H12LP 4 5 7 5 693 5/23/2016 May-19 H12LP 4 5 7 5 705 5/23/2016 May-19 H12LP 4 5 7 1 871 5/25/2016 May-19 H12LP 4 5 7 4 911 5/25/2016 May-19 H12LP 4 5 7 6 086 5/25/2016 May-19 H12LP 4 5 7 6 443 5/25/2016 May-19 H12LP 4 5 7 6 462 5/25/2016 May-19 H12LP 4 5 7 7 392 5/25/2016 May-19 H12LP 4 5 7 7 407 5/25/2016 May-19 H12LP 4 5 8 1 177 5/25/2016 May-19 H12LP 4 5 8 0 431 5/27/2016 May-19 H12LP 4 5 8 1 725 5/27/2016 May-19 H12LP 4 5 8 3 479 5/27/2016 May-19 H12LP 4 5 8 3 936 5/27/2016 May-19 H12LP 4 5 8 6 615 5/27/2016 May-19 H12LP 4 5 8 5 685 6/1/2016 Jun-19 H12LP 4 5 8 9 373 6/1/2016 Jun-19 H12LP 4 5 8 9 677 6/1/2016 Jun-19 H12LP 4 5 9 0 455 6/1/2016 Jun-19 H12LP 4 5 8 9 665 6/3/2016 Jun-19 H12LP 4 5 9 6 066 6/3/2016 Jun-19 H12LP 4 5 9 0 464 6/6/2016 Jun-19 H12LP 4 5 9 3 587 6/6/2016 Jun-19 H12LP 4 5 9 4 649 6/6/2016 Jun-19 H12LP 4 5 9 8 005 6/6/2016 Jun-19 H12LP 4 6 0 0 043 6/6/2016 Jun-19 H12LP 4 6 0 2 957 6/6/2016 Jun-19 H12LP 4 6 0 3 588 6/6/2016 Jun-19 H12LP 4 6 0 3 590 6/6/2016 Jun-19 H12LP 4 5 9 7 997 6/8/2016 Jun-19 H12LP 4 5 9 8 476 6/8/2016 Jun-19 H12LP 4 6 0 7 573 6/8/2016 Jun-19 H12LP 4 6 0 8 496 6/8/2016 Jun-19 H12LP 4 6 0 8 514 6/8/2016 Jun-19 H12LP 4 6 0 9 747 6/8/2016 Jun-19 H12LP 4 6 1 0 175 6/8/2016 Jun-19 H12LP 4 6 1 0 839 6/8/2016 Jun-19 H12LP 4 6 1 1 167 6/8/2016 Jun-19 H12LP 4 6 1 1 179 6/8/2016 Jun-19 H12LP 4 6 1 2 670 6/8/2016 Jun-19 H12LP 4 6 1 0 894 6/10/2016 Jun-19 H12LP 4 6 1 3 359 6/10/2016 Jun-19 H12LP 4 6 1 3 889 6/10/2016 Jun-19 H12LP 4 6 1 4 603 6/10/2016 Jun-19 H12LP 4 6 1 4 912 6/10/2016 Jun-19 H12LP 4 6 1 5 536 6/10/2016 Jun-19 H12LP 4 6 1 8 135 6/10/2016 Jun-19 H12LP 4 6 1 5 246 6/13/2016 Jun-19 H12LP 4 6 1 6 746 6/15/2016 Jun-19 H12LP 4 6 5 8 690 6/29/2016 Jun-19 H12LP 4 6 5 9 478 7/1/2016 Jul-19 H12LP 4 6 5 9 552 7/1/2016 Jul-19 H12LP 4 6 5 9 568 7/1/2016 Jul-19 H12LP 4 6 6 0 191 7/1/2016 Jul-19 H12LP 4 6 6 2 392 7/1/2016 Jul-19 H12LP 4 6 6 2 668 7/1/2016 Jul-19 H12LP 4 6 6 3 276 7/1/2016 Jul-19 H12LP 4 6 6 4 081 7/1/2016 Jul-19 H12LP 4 6 6 4 364 7/5/2016 Jul-19 H12LP 4 6 6 6 763 7/5/2016 Jul-19 H12LP 4 6 6 8 273 7/5/2016 Jul-19 H12LP 4 6 7 2 293 7/5/2016 Jul-19 H12LP 4 6 6 7 846 7/7/2016 Jul-19 H12LP 4 6 6 9 208 7/7/2016 Jul-19 H12LP 4 6 7 0 712 7/7/2016 Jul-19 H12LP 4 6 7 1 055 7/7/2016 Jul-19 H12LP 4 6 6 8 287 7/11/2016 Jul-19 H12LP 4 6 7 0 139 7/11/2016 Jul-19 H12LP 4 6 7 2 065 7/11/2016 Jul-19 H12LP 4 6 7 2 678 7/11/2016 Jul-19 H12LP 4 6 7 3 558 7/11/2016 Jul-19 H12LP 4 6 7 4 512 7/11/2016 Jul-19 H12LP 4 6 7 4 857 7/11/2016 Jul-19 H12LP 4 6 7 2 303 7/12/2016 Jul-19 H12LP 4 6 7 6 800 7/12/2016 Jul-19 H12LP 4 6 8 0 853 7/12/2016 Jul-19 H12LP 4 6 8 1 245 7/12/2016 Jul-19 H12LP 4 6 8 2 434 7/12/2016 Jul-19 H12LP 4 6 6 8 260 7/14/2016 Jul-19 H12LP 4 6 7 8 568 7/14/2016 Jul-19 H12LP 4 6 8 0 352 7/14/2016 Jul-19 H12LP 4 6 8 0 368 7/14/2016 Jul-19 H12LP 4 6 8 1 485 7/14/2016 Jul-19 H12LP 4 6 8 3 268 7/14/2016 Jul-19 H12LP 4 6 8 3 954 7/14/2016 Jul-19 H12LP 4 6 8 4 773 7/14/2016 Jul-19 H12LP 4 6 8 4 917 7/14/2016 Jul-19 H12LP 4 6 8 3 949 7/18/2016 Jul-19 H12LP 4 6 8 4 955 7/18/2016 Jul-19 H12LP 4 6 8 6 200 7/18/2016 Jul-19 H12LP 4 6 8 6 942 7/18/2016 Jul-19 H12LP 4 6 9 4 457 7/18/2016 Jul-19 H12LP 4 5 1 8 669 7/19/2016 Jul-19 H12LP 4 6 8 8 031 7/20/2016 Jul-19 H12LP 4 6 8 8 326 7/20/2016 Jul-19 H12LP 4 6 8 8 887 7/20/2016 Jul-19 H12LP 4 6 8 8 894 7/20/2016 Jul-19 H12LP 4 6 9 0 786 7/20/2016 Jul-19 H12LP 4 6 9 5 707 7/20/2016 Jul-19 H12LP 4 6 9 3 611 7/22/2016 Jul-19 H12LP 4 6 9 5 036 7/22/2016 Jul-19 H12LP 4 6 9 9 014 7/22/2016 Jul-19 H12LP 4 0 7 4 165 7/25/2016 Jul-19 H12LP 4 6 9 3 329 7/25/2016 Jul-19 H12LP 4 6 9 6 019 7/25/2016 Jul-19 H12LP 4 6 9 7 608 7/25/2016 Jul-19 H12LP 4 6 9 8 746 7/25/2016 Jul-19 H12LP 4 7 0 1 597 7/25/2016 Jul-19 H12LP 4 6 9 9 424 7/27/2016 Jul-19 H12LP 4 7 0 0 514 7/27/2016 Jul-19 H12LP 4 7 0 0 522 7/27/2016 Jul-19 H12LP 4 7 0 4 395 7/27/2016 Jul-19 H12LP 4 7 0 4 437 7/27/2016 Jul-19 H12LP 4 7 0 5 381 7/27/2016 Jul-19 H12LP 4 7 0 8 776 7/27/2016 Jul-19 H12LP 4 7 1 1 866 7/28/2016 Jul-19 H12LP 4 7 1 5 840 7/28/2016 Jul-19 H12LP 4 7 2 6 685 7/29/2016 Jul-19 H12LP 4 7 3 0 128 7/29/2016 Jul-19 H12LP 4 7 3 1 690 7/29/2016 Jul-19 H12LP 4 7 4 1 142 7/29/2016 Jul-19 H12LP 4 7 4 0 540 8/1/2016 Aug-19 H12LP 4 7 4 1 157 8/1/2016 Aug-19 H12LP 4 7 4 4 985 8/1/2016 Aug-19 H12LP 4 7 4 5 359 8/1/2016 Aug-19 H12LP 4 7 4 5 889 8/1/2016 Aug-19 H12LP 4 7 4 6 386 8/1/2016 Aug-19 H12LP 4 7 4 9 418 8/1/2016 Aug-19 H12LP 4 7 4 9 402 8/3/2016 Aug-19 H12LP 4 7 5 0 299 8/3/2016 Aug-19 H12LP 4 7 5 1 118 8/3/2016 Aug-19 H12LP 4 7 5 3 896 8/5/2016 Aug-19 H12LP 4 7 5 3 906 8/5/2016 Aug-19 H12LP 4 7 5 7 161 8/5/2016 Aug-19 H12LP 4 7 6 0 422 8/5/2016 Aug-19 H12LP 4 7 6 2 156 8/8/2016 Aug-19 H12LP 4 7 6 6 617 8/8/2016 Aug-19 H12LP 4 7 6 6 751 8/8/2016 Aug-19 H12LP 4 7 4 8 478 8/9/2016 Aug-19 H12LP 4 7 7 2 854 8/11/2016 Aug-19 H12LP 4 7 7 6 931 8/11/2016 Aug-19 H12LP 4 7 7 7 716 8/11/2016 Aug-19 H12LP 4 7 8 6 543 8/12/2016 Aug-19 H12LP 4 7 8 9 098 8/12/2016 Aug-19 H12LP 4 7 9 3 711 8/15/2016 Aug-19 H12LP 4 7 9 9 173 8/17/2016 Aug-19
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA
  • Descripción del producto
    Reprocessed Xcel Bladeless Trocar (H12LP) || Model # H12LP || Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA