Events

Device Recall Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components 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
    50150
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0911-2010
  • 사례 시작날짜
    2006-02-17
  • 사례 출판 날짜
    2010-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74834
  • 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 orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of x# polyethylene used on scorpio, triathlon and trident inserts.
  • 조치
    Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.

Device

Device Recall Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 35458101; 36121101; 36121401; 36209601; 36209701; 35904301; 35904501; 35904701; 36294401; 36297801; 36605701; 36297902; 36605801; 35904901; 36298101; 35905001; 36298201; 35905101; 35905301; 36295101; 35905501; 36298801; 36298902; 36299301; 35906001; 36007001; 36301001; 36007101; 36301301; 36862701; 36011001; 36606201; 36606401; 36011801; 36301501;  36012201; 36012301; 36301901; 36012901; 36302001; 36013001; 36013401; 36302101; 36302301; 36014501; 36014701A 36014801; V145; V146; V148; V161; V162; V163; V165; V166; V024C and V026C.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States and Canada.
  • 제품 설명
    Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. || Intended to be used with cemented or cementless components in primary or revision total knee arthroplasty.
  • 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