Device Recall Stryker 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 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
    65646
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1846-2013
  • 사례 시작날짜
    2013-05-21
  • 사례 출판 날짜
    2013-07-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-10-14
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • 원인
    Stryker osteosynthesis has become aware that left gamma3 nails are marked as right nails.
  • 조치
    Stryker sent notification letters and product accountability forms dated May 21, 2013. via Fed Ex with return receipt to all branches/agencies and on May 22, 2013, via Fed Ex with return receipt to all hospital risk management, chief of orthoapedics, and surgeons. Our records indicate that you may have received and/or used the above referenced product(s). It is Stryker's¿¿ responsibility as the manufacturer to ensure that customers who may have received and/or used these affected products also receive this important communication. Please contact your Stryker¿¿ Sales Representative to arrange for return of the product if you have any of the above listed items. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 855- 251-3635. Please note that your signature on the following form only confirms that you received this notification and does not obligate you to take any additional action beyond what is called for in this notification letter. We regret any inconvenience this action may cause you and if you have any questions, please call (201) 972-2100.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number- 33250400S Catalog Number 33250360S
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution including the states of IL, KY and TN.
  • 제품 설명
    GAMMA3 System Long Nail Kit, R2.0, Ti, Left || Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA || A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • 제조사 모회사 (2017)
  • Source
    USFDA