Events

Device Recall PowerProMax 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linvatec Corp. dba ConMed Linvatec 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
    52803
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1951-2009
  • 사례 시작날짜
    2009-07-31
  • 사례 출판 날짜
    2009-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84037
  • 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
    Battery Single Trigger - Product Code HRX
  • 원인
    There is a potential the devices may self activate for their powerpro, powerpromax, and mpower i handpieces manufactured prior to june 1, 2008.
  • 조치
    Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169. Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units.

Device

Device Recall PowerProMax
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including United States.
  • 제품 설명
    PowerProMax PRO5100M Battery Single Trigger, || PowerProMax PRO5200M Battery Two Trigger, || PowerProMax PRO5250M Battery Two-Trigger Standard, || PowerProMax PRO5300M Battery Oscillator, || PowerProMax PRO5400M Battery Reciprocator, and || PowerProMax PRO6200 Battery Single Trigger. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • 제조사 주소
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA