Events

Device Recall MEDPOR TITAN 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Howmedica Osteonics Corp dba Stryker Craniomaxillofacial 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
    60964
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0922-2012
  • 사례 시작날짜
    2011-12-16
  • 사례 출판 날짜
    2012-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106899
  • 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
    Mesh, surgical - Product Code FTM
  • 원인
    The template that is packaged with this implant was not packaged according to specification. the template was packaged in a single pouch instead of a double pouch.
  • 조치
    "Urgent Product Recall" Notification letters and Product Accountability Forms have been sent on January 13, 2012 domestically via FedEx and Internationally via DHL. Customers were informed of the product problem and provided risk mitigation information. Return of the Product Accountability/Acknowledgement form was requested. Questions were directed to 770-254-4423.

Device

Device Recall MEDPOR TITAN
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 81038, Lot Code: F001357
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
  • 제품 설명
    MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
  • Manufacturer
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial

Manufacturer

Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
  • 제조사 주소
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial, 15 Dart Rd, Newnan GA 30265-1017
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA