Events

PopLok" Knotless Suture Anchor with Disposable Driver 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed 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
    77039
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0253-2018
  • 사례 시작날짜
    2017-04-17
  • 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=154857
  • 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
    Manufactured with the incorrect anchor outer body.
  • 조치
    On April 17, 2017 CONMED distributed Urgent Device Recall notices and business reply forms to customers via USPS First Class. Customers are instructed to stop use of the devices immediately and to review inventory for any of the affected product. CONMED requests that customers contact all departments within their facilities and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive the notice and respond immediately. Customers who have received affected product are expected to complete the Business Reply Form and return it with unused devices. Customers who do not have any affected devices to return are still advised to complete and return the Business Reply Form via email to: largpop@conmed.com. Customers with questions can contact the Field Action Support Team at 1-800-237-0169.

Device

PopLok" Knotless Suture Anchor with Disposable Driver
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 786351
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
  • 제품 설명
    Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA