Events

Device Recall Serrated Soft Tissue Shields 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 X Spine Systems 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
    68863
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2136-2014
  • 사례 시작날짜
    2014-07-11
  • 사례 출판 날짜
    2014-08-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128882
  • 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
    Guide, surgical, instrument - Product Code FZX
  • 원인
    Revision b of the tissue shields of the device was 7 mm longer than the previous design.
  • 조치
    X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410

Device

Device Recall Serrated Soft Tissue Shields
  • 모델명 / 제조번호(시리얼번호)
    Part numbers X079-0096 and X079-0097 with Lot #12320
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of FL and MO.
  • 제품 설명
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • 제조사 주소
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • 제조사 모회사 (2017)
    X-Spine Systems, Inc
  • Source
    USFDA