Events

Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R) 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
    62240
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1934-2012
  • 사례 시작날짜
    2012-03-07
  • 사례 출판 날짜
    2012-07-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110004
  • 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
    Countersink - Product Code HWW
  • 원인
    Aesculap implant systems, llc has initiated a voluntary removal of the s4 cervical (s4c) occiput revision instrument that is part of the s4c occipital instrument set. the instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
  • 조치
    The firm initiated their recall of this product by issuing an "Important Product Removal Notification" letter to all consignees dated March 7, 2012. The letter described the problem, advised them not to use the product, and instructed consignees to return the instruments to the recalling firm with the attached Distribution Inventory Sheet. Customer Service may be contacted if questions at 1-866-229-3002.

Device

Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R)
  • 모델명 / 제조번호(시리얼번호)
    All distributed lot numbers and serial numbers
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
  • 제품 설명
    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
  • 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