Events

Device Recall Synthes Spine Click X Pedicle Screw 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA HQ, 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
    64173
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0938-2013
  • 사례 시작날짜
    2013-01-11
  • 사례 출판 날짜
    2013-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115816
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • 원인
    Lot number 7542279, of the 45 mm click 'x pedicle screw (part number 487.072), was incorrectly etched as "click 'x pedicle screw 05.2 l40 tan violet" although the actual length of the screw is 45 mm.
  • 조치
    The firm initiated a recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter, dated January 11, 2013, to all consignees. The letter identified the affected product and the issue, as well as requested that consignees examine their inventory for the product(s) with the identified Part and Lot Numbers, remove them from use, and return them to Synthes. Customers were to follow the steps provided in the letter regarding if they had or did not have any of the identified affected product. Questions were to be directed to 610-719-5450 or Fieldaction@synthes.com.

Device

Device Recall Synthes Spine Click X Pedicle Screw
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 7542279
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
  • 제품 설명
    Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. || Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • 제조사 주소
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA