Events

Device Recall CrossFT Suture Anchor with Two 2 HiFi Sutures 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linvatec Corp. dba ConMed Linvatec 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
    58936
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2703-2011
  • 사례 시작날짜
    2011-01-26
  • 사례 출판 날짜
    2011-06-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100643
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • 원인
    Conmed linvatec, largo, fl is recalling crossft suture anchor with two #2 hi-fi sutures, lot 211581, product number cfp-5502. there is a possibility that the product may have been incorrectly assembled. the disposable driver may have the incorrect color handle (red versus black).
  • 조치
    ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product. Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com.

Device

Device Recall CrossFT Suture Anchor with Two 2 HiFi Sutures
  • 모델명 / 제조번호(시리얼번호)
    Lot 211581
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.
  • 제품 설명
    "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" || The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • 제조사 주소
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA