Events

Device Recall Integra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corporation 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
    73689
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2777-2016
  • 사례 시작날짜
    2016-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-09-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144759
  • 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
    Device, dermal replacement - Product Code MDD
  • 원인
    Integra's post qa release review of historical product release test results for meshed idrt products identified the peel strength test average result was incorrectly calculated for a single lot (lot 105a00324750).
  • 조치
    Integra LifeSciences Inc. sent an urgent voluntary medical device recall letter/recall acknowledgement and return form dated March 11. 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product and immediately stop using and remove from service. Customers were asked to complete the attached form and return by email or fax as indicated on the form. Customers with questions were advised to contact Customer Service at 1-888-601-0203. For questions regarding this recall call 609-275-2700.

Device

Device Recall Integra
  • 모델명 / 제조번호(시리얼번호)
    Catalogue No. MIDRT 8101 Lot No. 105A00324750
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to PA
  • 제품 설명
    Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only || Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient || Manufactured by: || Integra LifeSciences Corporation || 311 Enterprise Drive, Plainsboro, NJ 08536 || 877-444-1122 USA n 609-936-5400 outside USA || 866-800-7742 fax
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation