Events

Device Recall Arsenal Spinal Fixation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alphatec Spine, Inc. 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
    77220
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2249-2017
  • 사례 시작날짜
    2017-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155473
  • 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
    Thoracolumbosacral pedicle screw system - Product Code NKB
  • 원인
    Alphatec spine is recalling the arsenal spinal fixation system set screw due to a trend in set screw postoperative disengagement from the screw body.
  • 조치
    An Urgent Medical Device Recall notification letter dated 5/8/17 will be sent to customers to inform them that as a result of discussions with the FDA regarding a related recall of Arsenal Set Screw part number 47127, Alphatec Spine has made the decision to recall the original Arsenal Set Screw part number 47027. This action will remove all remaining pieces of part number 47027 from the domestic (U.S.) market and the Japan market. Arsenal set screw part number 47127 was recalled in September 2016. Arsenal set screw part number 4 7027 was not included in the recall because the complaints associated with 47027 were within acceptable safety limits and remains so presently. Alphatec has received eight (8) complaints for disengagement of set screw 47027 since the product was introduced to the market on June 14, 2014, which equates to a disengagement failure rate for P/N 47027 of 0.095%. Customers are informed of the actions to be taken. Customers are instructed to fill out the last page of recall letter to confirm that you have read this notification and have taken all necessary actions as described in this notification.

Device

Device Recall Arsenal Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    671949 681640 684646 687843 690206 692720 693064 671948 681641 684646 687843 690206 692705 674136 681642 684647 687847 690210 692718 674137 682061 686374 687847 691848S1 692719 674431 682060 684645 689847 691848 692855 674432 682062 686372 689847 691849 692855 674433 682063 686375 689849 692597 692706 671950 684429 687839 690127 692597 692864 674429 684430 687839 689848 692364 692910 674430 684432 687840 690207 692598 692911 681638S1 684644 687840 690207 691590 692911 681638 684433 687842 690208 692599 693065 681639 684431 687845 690209 692704 693057
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan
  • 제품 설명
    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 || Product Usage: || The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • 제조사 주소
    Alphatec Spine, Inc., 5830 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
    Alphatec Spine Inc
  • Source
    USFDA