Device Recall DRP SCREW 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 In2Bones, SAS 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
    76104
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0953-2017
  • 사례 시작날짜
    2016-12-19
  • 사례 출판 날짜
    2017-01-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-02-01
  • 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
    Plate, fixation, bone - Product Code HRS
  • 원인
    Dimensional non-conformity of the thread on the screw head.
  • 조치
    IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below: 1. Identify all the devices with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only: Identify all the devices with the batches subject of this recall that were delivered to your customers, and if relevant, instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to comply with the recommendations listed. This fax back form will enable In2Bones to conduct effectiveness checks. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at +33 4 72 29 26 26 / +33 7 61 88 44 30 or by email: qualte@in2bones.com. For questions regarding this recall call 844-602-6637.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1604154, 1605083, 1606068
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US TN only and Internationally to France and Switzerland
  • 제품 설명
    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France || The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
  • Manufacturer

Manufacturer

  • 제조사 주소
    In2Bones, SAS, 28 Chemin du petit Bois, Ecully France
  • 제조사 모회사 (2017)
  • Source
    USFDA