Events

GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; || GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; || GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; || GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217 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
    76988
  • 사례 위험등급
    Unclassified Correction
  • 사례 시작날짜
    2017-03-28
  • 사례 상황
    Firm initiated action, Not yet classified 1
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154779
  • 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
    Motor, Surgical Instrument, Ac-Powered - Product Code GEY
  • 원인
    Diamond particulates may break off the burr and fall into the surgical site. if the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. these particulates could also lead to mechanically induced soft tissue damage.
  • 조치
    On April 7, 2017 8 Hospitals, 3 distributors and 11 sales reps were sent an Urgent Medical Device Recall Notification letter. Letters were sent UPS overnight. Customers were asked to immediately discontinue use and return the product to Aesculap, Inc.

Device

GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0...
  • 모델명 / 제조번호(시리얼번호)
    Model numbers:  GP321R ; GP322R ; GP323R ; GP324R ; GP325R ;
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    CA, IL, NY, PA, TN, TX
  • 제품 설명
    GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; || GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; || GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; || GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0;
  • Manufacturer
    Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217

Manufacturer

Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217