Events

Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, 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
    76824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1843-2017
  • 사례 시작날짜
    2017-03-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154320
  • 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
    Bit, surgical - Product Code GFG
  • 원인
    Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.
  • 조치
    Smith &n; Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600.

Device

Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM
  • 모델명 / 제조번호(시리얼번호)
    Batch Numbers: F92143, F92147, G10380, G10382, G11216, G11217 G11231, G11232, G15940, G15943, G18835, G18836, G30219 G30220, G30254, G30255, G32180, G32182, G32183, G32184
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
  • 제품 설명
    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM || Product Number: 72204042 || The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 130 & 120 Forbes Blvd, Mansfield MA 02048
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA