Events

Device Recall ConMed Hip Preservation System Signature Series 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
    73123
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1842-2016
  • 사례 시작날짜
    2015-12-21
  • 사례 출판 날짜
    2016-05-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143103
  • 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
    Bur, surgical, general & plastic surgery - Product Code GFF
  • 원인
    Metal shavings released from burs during use are due to contact between the bur and the hood of the prebent bur assembly. during the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
  • 조치
    ConMed sent an Urgent Medical Device Recall Notification letter dated December 17, 2015, to all affected customers. Customers are urged to stop use and return these devices immediately. Customers who have further distributed these items are urged to contact all of those organizations immediately and provide a copy of the recall notification letter. It is imperative that all end users of these devices receive the recall notice and respond immediately. Customers with questions can call 315-624-3237 or email largohpshb@conmed.com. The devices should be returned to ConMed Corporation NCR-47057 11155 Concept Blvd. Largo, FL 33773. For questions regarding this recall call 315- 624-3533.

Device

Device Recall ConMed Hip Preservation System Signature Series
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1) 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136; 2) 569462, 577800, 577971 & 579652; 3) 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales
  • 제품 설명
    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 || The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic 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