Device Recall Synthes Vertebropasty Needle Kit 10g Diamond Tip 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
    66414
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0410-2014
  • 사례 시작날짜
    2013-07-30
  • 사례 출판 날짜
    2013-11-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • 원인
    Complaints were received of inconsistencies in the expiration dates shown on the packaging of the vertebroplasty needle kit 10g diamond tip device.
  • 조치
    Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part No. 03.702.218S, Lot No. AJM838X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including IN, MT, HI, and FL.
  • 제품 설명
    Vertebroplasty Needle Kit 10g Diamond Tip || Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
  • Manufacturer

Manufacturer

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