Device Recall UltOS 3.5mm locking screw (12mm to 50mm) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ortho Solutions Inc 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
    71899
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0026-2016
  • 사례 시작날짜
    2015-07-14
  • 사례 출판 날짜
    2015-10-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-04-26
  • 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
    Screw, fixation, bone - Product Code HWC
  • 원인
    Ortho solutions inc is initiating a recall on behalf of ultos 3.5mm locking screw. the locking thread feature of the screw was not manufactured to specification. as a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. in the event of this occurring the non functioning screw would need to be replaced with an alternativ.
  • 조치
    The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015. If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
  • 제품 설명
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile || Orthopaedic Bone Screw
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ortho Solutions Inc, 330 Franklin Tnpk, Mahwah NJ 07430
  • 제조사 모회사 (2017)
  • Source
    USFDA