Events

Device Recall Glenoid Head Inserter (RSP Inserter/Impactor) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Encore Medical, Lp 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
    56220
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2636-2010
  • 사례 시작날짜
    2010-07-12
  • 사례 출판 날짜
    2010-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92992
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Complaints indicate product's distal threaded tip may fracture under certain circumstances.
  • 조치
    DJO Surgical sent an "Urgent Field Safety Notice" Letter dated July 12, 2010, to all of their consignees. The letter described the product, the problem, and the action consignees should take. Consignees were instructed to: Contact their Customer Service Representative for an R-RPR (RMS) number and return all RSP Glenoid Head Inserters, 804-03-041, under the assigned number to receive credit. Complete and return the Field Safety Notice Response to the firm. Identify and inform any customers who were sold or received the product of the Field Safety Notice Any questions consignees should call the firm at (512) 834-6330.

Device

Device Recall Glenoid Head Inserter (RSP Inserter/Impactor)
  • 모델명 / 제조번호(시리얼번호)
    Device Part #804-03-041, All Lots.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, including the states of AR, AZ, CA, FL, GA, ID, IL, IN, LA, MA, ME, MI, MO, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, and WI; and the countries of Puerto Rico, Germany, and Saudi Arabia.
  • 제품 설명
    Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. || Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA