Events

Device Recall STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Corporation 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
    78668
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0837-2018
  • 사례 시작날짜
    2017-11-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162096
  • 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
    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
  • 조치
    On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.

Device

Device Recall STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw
  • 모델명 / 제조번호(시리얼번호)
    Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed domestically to . Distributed internationally to Australia and Mexico.
  • 제품 설명
    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • 제조사 주소
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA