Device Recall Reprocessed Xcel Bladeless Trocar (H12LP) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Sustainability Solutions 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    75675
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0765-2017
  • 사례 시작날짜
    2016-11-11
  • 사례 출판 날짜
    2016-12-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-05-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
  • 원인
    An increase in reports indicating that the reprocessed h12lp trocar adjustable plug may break in the packaging or during use.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA
  • 제품 설명
    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

  • 제조사 주소
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • 제조사 모회사 (2017)
  • Source
    USFDA