Events

Device Recall Stryker Orthobiologics Aliquot Catheter, 8", Part Number 21100526 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Orthovita, Inc., dBA Stryker Orthobiologics. 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
    63204
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1392-2013
  • 사례 시작날짜
    2012-11-10
  • 사례 출판 날짜
    2013-05-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115059
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • 원인
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • 조치
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.

Device

Device Recall Stryker Orthobiologics Aliquot Catheter, 8", Part Number 21100526
  • 모델명 / 제조번호(시리얼번호)
    Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • 제품 설명
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 || Product Usage: || Facilitate placement of bone cement in weakened or diminished bone
  • Manufacturer
    Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.
  • 제조사 주소
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA