Events

Device Recall Restoration Modular Conical Distal Stem 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
    50498
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0884-2009
  • 사례 시작날짜
    2008-11-21
  • 사례 출판 날짜
    2009-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75529
  • 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
    prosthesis, hip - Product Code LZO
  • 원인
    Stryker became aware of a lot for lot mix up.
  • 조치
    Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.

Device

Device Recall Restoration Modular Conical Distal Stem
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 6276-7-017 (17mm), Lot Code CAXHA68D; Catalog No. 6276-7-014, (14mm) Lot Code CAXHB18A
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Class II Recall - Nationwide Distribution
  • 제품 설명
    Restoration Modular Conical Distal Stem; || Sterile, Titanium Alloy. One unit per package. || Stryker Ireland || Carrigtwohill County Cork, Ireland. || Authorized Representative in Europe: Stryker France, Cedex France. || This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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