Events

Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM 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
    64669
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1132-2013
  • 사례 시작날짜
    2013-03-06
  • 사례 출판 날짜
    2013-04-17
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116740
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • 원인
    One batch of 4.5 mm diameter trigen low-profile bone screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
  • 조치
    Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 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 cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.

Device

Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 12FM12182
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
  • 제품 설명
    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA || orthopedic surgery
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • 제조사 주소
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA