Events

UniCP Compression Forceps (spreader) 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
    49561
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0307-2009
  • 사례 출판 날짜
    2008-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-05-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73813
  • 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
    Bone Fixation Plate - Product Code HRS
  • 원인
    Reports of the uni-cp compression forceps breaking during the compression of the uni-cp plate.
  • 조치
    Recall Notice letters were sent to all Integra Sales Specialists on September 30, 2008 by first class mail. The letter informed them of the product and the problem concerning the product. The Sales Specialists were asked to return all inventories under their control with part number 339001ND from lots E6WS, E7UY, & E86M. They are required to fill out the attached form identifying the lot number for all Newdeal Compression Forceps (Spreader) in their inventory along with the serial number(s) of their Uni-CP set(s). The form should be filled out even if the sales specialist does not have a Uni-CP. The form should be faxed or mailed back to Walt Ryan in Customer Service, 609-799-3297. A RMA number will be generated for the return of any affected inventory. A replacement will be sent and upon receipt, the forceps (spreader) should be replaced and returned to the address indicated on the letter.

Device

UniCP Compression Forceps (spreader)
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers E6WS, E7UY and E86M.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Uni-CP Compression Forceps (spreader); || Non-sterile, R only, Catalog number: 339001ND || Newdeal, Lyon, France; || Integra, 411 Enterprise Drive, Plainsboro, NJ 08536 || Intended to open the UNI-Compression Plate olive, which creates a compression.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp