Events

TRIGEN INTERTAN NAIL 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
    68043
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1636-2014
  • 사례 시작날짜
    2014-04-04
  • 사례 출판 날짜
    2014-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126851
  • 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
    Nail, fixation, bone - Product Code JDS
  • 원인
    A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
  • 조치
    The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.

Device

TRIGEN INTERTAN NAIL
  • 모델명 / 제조번호(시리얼번호)
    TRIGEN INTERTAN NAIL:  (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190   (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750  (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494  (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660  (5) REF 71675205, Lot Number 13LT36598  (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672  (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963  (8) REF 71675211, Lot Number 13LT36313
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
  • 제품 설명
    TRIGEN INTERTAN NAIL: || (1) REF 71675201, 10 MM X 18 CM, 125 degree, || (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, || (3) REF 71675203, 13 MM X 18 CM, 125 degree, || (4) REF 71675204, 10 MM X 20 CM, 125 degree, || (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, || (6) REF 71675207, 10 MM X 18 CM, 130 degree, || (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, || (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, || Smith & Nephew, Inc. Orthopedic fixation device.
  • 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