Events

Device Recall Synthes Titanium Midface Distractor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA HQ, Inc. 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
    64287
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0942-2013
  • 사례 시작날짜
    2013-01-11
  • 사례 출판 날짜
    2013-03-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115763
  • 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
    Plate, bone - Product Code JEY
  • 원인
    There is the potential for the anterior footplates to not fit onto the titanium midface distractor assembly as the tab of some distractors may be oversized.
  • 조치
    The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to all consignees. The letter identified the affected product and the problem. Also, the firm requested consignees to examine their inventory for products(s) with the specified part number, remove them from use, and return them to Synthes. Customers were to follow the instructions provided on what to do if they have or do not have any identified affected product. Questions should be directed to 610-719-5450 or FieldAction@synthes.com.

Device

Device Recall Synthes Titanium Midface Distractor
  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
  • 제품 설명
    Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • 제조사 주소
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA