Device Recall Synthes 5.0mm Variable Locking Screw 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes, 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
    67498
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1125-2014
  • 사례 시작날짜
    2014-02-05
  • 사례 출판 날짜
    2014-03-04
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-08-31
  • 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
    condylar plate fixation Implant - Product Code JDP
  • 원인
    Labeling correction: the package insert in one 5.0mm variable locking screw package was a gp0006 (anterior cervical vertebrae plate system) insert, which should have been a gp2848 (4.5mm va-lcp curved condylar plate system insert).
  • 조치
    Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Exchage the previously shipped package insert (GP0006) with the correct package insert (GP2848 provided with the notification). Review the package insert. Forward the Field Safety Notification to anyone in their facility that needs to be informed. If the package insert has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all package inserts have been exchanged. Maintain a copy of the notice. Customers with questions were instructed to maintain a copy of the notice. For questions regarding this recall call 610-719-5000.

Device

  • 모델명 / 제조번호(시리얼번호)
    part no. 02.231.240, lot no. 823111
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.
  • 제품 설명
    Synthes 5.0mm Variable Locking Screw || This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
  • Manufacturer

Manufacturer

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