Events

Device Recall Aesculap SIBD 4 degree Trial Implant (SJ768TUS) and Aesculap SIBD 9 degree Trial Implant (SJ780TUS 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
    62626
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2114-2012
  • 사례 시작날짜
    2012-07-12
  • 사례 출판 날짜
    2012-07-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111198
  • 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 4 degree and 9 degree trial instruments (sj768t-us/sj780t-us) are correctly dimensioned, but the part number etched on the instrument may be incorrect. the 4 degree trial instrument (sj768t-us) may be marked with the incorrect part number of the 9 degree trail instrument (sj780t-us) and the 9 degree trial instrument (sj780t-us) may be marked with the incorrect part number of the 4 degree tria.
  • 조치
    Aesculap sent an Important Product Removal Notification letter dated July 11, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product by contacting their local sales representative or the customer service department at 1-866-229-3002 for a Returned Goods Request )RGR) number. Customers were asked to complete and return the Distribution Inventory Sheet. For questions call 610-984-9260 or 610-984-9274.

Device

Device Recall Aesculap SIBD 4 degree Trial Implant (SJ768TUS) and Aesculap SIBD 9 degree Trial I...
  • 모델명 / 제조번호(시리얼번호)
    4 degree - SJ768T-US and 9 degree SJ780T-US
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - including the states of CO, OH, OK and TX.
  • 제품 설명
    Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) || Product Usage: || The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
  • 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