Events

Device Recall TITAN 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    79597
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1463-2018
  • 사례 시작날짜
    2017-12-20
  • 사례 출판 날짜
    2018-04-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162744
  • 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
    Template - Product Code HWT
  • 원인
    Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. all cases resulted in a delay in surgery, with a variance of medical intervention required.
  • 조치
    Firm sent letters to consignees on December 20, 2017. Firm asked consignees to examine inventory and determine if consignee had affected product. Firm promised to send new stem trials along with a return shipping label. Firm asked to complete the Acknowledgment and Return Form and email or fax back to firm. For further questions, please call (609) 275-0500.

Device

Device Recall TITAN
  • 모델명 / 제조번호(시리얼번호)
    TRL092002506  Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177  TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178  TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179  TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710  TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711  TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712  TRL092002512  Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713  TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714  TRL092002514  Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715  TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716  TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution.
  • 제품 설명
    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: || Catalog Number Product Description || TRL092002506 Humeral Stem Trial, 6mm || TRL092002507 Humeral Stem Trial, 7mm || TRL092002508 Humeral Stem Trial, 8mm || TRL092002509 Humeral Stem Trial, 9mm || TRL092002510 Humeral Stem Trial, 10mm || TRL092002511 Humeral Stem Trial, 11mm || TRL092002512 Humeral Stem Trial, 12mm || TRL092002513 Humeral Stem Trial, 13mm || TRL092002514 Humeral Stem Trial, 14mm || TRL092002515 Humeral Stem Trial, 15mm || TRL092002516 Humeral Stem Trial, 16mm
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.