Events

Orthopedic Template 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aesculap Implant Systems LLC 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
    79042
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0591-2018
  • 사례 시작날짜
    2017-08-10
  • 사례 출판 날짜
    2018-02-12
  • 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=161225
  • 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
    Template - Product Code HWT
  • 원인
    The ns357r vega ps tibia trial/preparation plateau size t4 may be incorrectly labeled. if the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
  • 조치
    On August 21, 2017 an Urgent Medical Device Recall notification was issued titled "NS357R Tibia Trial Plateau" asking distributors to inspect Sets #0468 and follow the inspection instructions on the customer notification letter and immediately remove the affected part and return to Aesculap Implant Systems. Questions or concerns can be directed to Customer Service at 314-551-5998

Device

Orthopedic Template
  • 모델명 / 제조번호(시리얼번호)
    The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA (nationwide)
  • 제품 설명
    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) || The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • 제조사 주소
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • 제조사 모회사 (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA