Events

Device Recall Turon 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
    52701
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1992-2009
  • 사례 시작날짜
    2009-07-20
  • 사례 출판 날짜
    2009-09-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83676
  • 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
    Shoulder Metal/Polymer Semi-Constrained Uncemented Prosthesis - Product Code MBF
  • 원인
    Product devices used for testing are not identical to what was manufactured. under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.
  • 조치
    Firm notified consignees by an Urgent: Medical Device Recall letter, dated July 20, 2009. The letter stated the reason for the recall, asked customers to quarantine, and return the affected product. The enclosed response form needed to be completed and returned as soon as possible. Questions were to be directed to David Harris, Manager of Customer Service at 512-834-6330.

Device

Device Recall Turon
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 53987943, 53987944, 53987945, 53987946, and 53987947.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- Including states of TX, FL, and GA.
  • 제품 설명
    Turon Revision Glenoid Poly Liner. || The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. || DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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