Events

Positioner/Aligner 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Limacorporate S.p.A 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
    78109
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0068-2018
  • 사례 시작날짜
    2017-09-08
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158680
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
  • 조치
    The Firm, Lima Corporate has notified the US agents of the recall and asked to check each single set with the affected product codes, identify the items and remove them from the inventory. The US distributors have also been instructed to fill out and sign a response document specifying the quantities returned. For further questions, please call (800) 962-2578.

Device

Positioner/Aligner
  • 모델명 / 제조번호(시리얼번호)
    Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
  • 제품 설명
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 || Used during implantation of the Delta Acetabular System
  • Manufacturer
    Limacorporate S.p.A

Manufacturer

Limacorporate S.p.A
  • 제조사 주소
    Limacorporate S.p.A, Via Nazionale 52, Frazione Villanova, San Daniele del Friuli Italy
  • 제조사 모회사 (2017)
    Emil Holding Ii Sarl
  • Source
    USFDA