Device Recall ReSolve Halo Open Back Halo Ring 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ossur Engineering, 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
    50706
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1508-2009
  • 사례 시작날짜
    2008-11-09
  • 사례 출판 날짜
    2009-06-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-04-22
  • 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
    Skull Tong for Traction - Product Code HAX
  • 원인
    Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
  • 조치
    Ossur contacted direct consignees and sub-accounts beginning on November 10 , 2008 via a phone call informing them of the recall, and the reason as stated in the public reason for recall. Consignees were asked to check their inventory for any of the identified products and contact them with this information. The firm developed a telephone script for the customer service representatives to use. Ossur then forwarded a notification letter to the affected customers beginning on November 12, 2008 via US Postal Service. In the event that any of these parts have already been applied to a patient, Ossur advised customers to follow their normal follow-up protocols, ensuring that the ceramic pins are properly fixed in the skull. At the time of the phone calls Ossur did not have sterilized open back replacement rings available; however, they offered their ReSolve Closed Back Halo ring as an alternative. The firm estimated that the normal product offering should be available once again in approximately four to six weeks from the date of the phone call.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 08033120, 08040201, 08050204, 08051414, 08060514, 08070706, 08080710, 08091521, 08093027, and 08102723.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    ReSolve Halo - Open Back Halo Ring, Model Number: 505400D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ossur Engineering, Inc, 910 Burstein Dr, Albion MI 49224-4011
  • 제조사 모회사 (2017)
  • Source
    USFDA