Events

Device Recall Kinemax Stem Extenders 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
    70784
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1614-2015
  • 사례 시작날짜
    2015-02-27
  • 사례 출판 날짜
    2015-05-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134666
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (kinemax stem extenders, 80 mm) there was a different part #6476-8-250 (kinemax stem extenders, 40 mm.
  • 조치
    Stryker Orthopaedics an Urgent Medical Device Recall Letter/Notification Acknowledgement Form dated April 9, 2015 to their affected customers. The recall letter identified the affected product, problem and actions to be taken. Customers are asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of the product if they have any of the affected items. Customers are asked to complete and return the acknowledgement form within 5 days by emailing to: so_m_product_field_action_response@stryker.com or faxed to: 1-855-251-3635. For question call 201-831-6365.

Device

Device Recall Kinemax Stem Extenders
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 6476-8-260, Lot code: EJPLC
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide distribution in the states of MA and RI.
  • 제품 설명
    Kinemax Stem Extenders, 80 mm, || Product Usage: || Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.
  • 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