Device Recall Farabeuf Clamp for 3.5mm Screws PRO 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker GmbH 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
    80198
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2244-2018
  • 사례 시작날짜
    2018-05-04
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Clamp - Product Code HXD
  • 원인
    Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm.
  • 조치
    On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. Customers with questions may call 201-831-5000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot # 04857V
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
  • 제품 설명
    Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker GmbH, Bohnackerweg 1, Selzach Switzerland
  • 제조사 모회사 (2017)
  • Source
    USFDA