Events

Triathlon MIS AP Sizer Body 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
    45540
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0448-2008
  • 사례 시작날짜
    2006-09-19
  • 사례 출판 날짜
    2007-12-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-01-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65754
  • 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
    MIS AP Sizer Body - Product Code JWH
  • 원인
    Assembly problems: mis instruments (triathlon mis ap sizer body - left; triathlon mis sizer body - right; triathlon mis femoral adjustment block and triathlon mis modular capture) may not assemble properly.
  • 조치
    Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.

Device

Triathlon MIS AP Sizer Body
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right; All lot codes
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.
  • 제품 설명
    Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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