Events

Device Recall Imbibe Bone Marrow Aspiration Needle 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
    69979
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0938-2015
  • 사례 시작날짜
    2014-12-04
  • 사례 출판 날짜
    2015-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132096
  • 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
    Instrument, biopsy - Product Code KNW
  • 원인
    There is the potential for a breach in the inner or outer packaging pouches of all lots of the imbibe bone marrow aspiration needle.
  • 조치
    The firm, Stryker, sent an "URGENT PRODUCT RECALL" letter dated December 4, 2014, to end users/customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to complete and return the URGENT MEDICAL DEVICE RECALL NOTIFICATION ACKNOWLEDGMENT FORM within 5 days via fax to 215-253-5020, contact other hospitals in your territory that have the affected products to arrange return of the product, and return the affected product to: Stryker Orthobiologics, 67 Great Valley Parkway, Malvern, PA 19355. If you have any questions, feel free to contact the Associate Manager, Quality Assurance and Regulatory Compliance at 610-640-1775 x 5299.

Device

Device Recall Imbibe Bone Marrow Aspiration Needle
  • 모델명 / 제조번호(시리얼번호)
    all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • 제품 설명
    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch || 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch || 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch || 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch || 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch || intended for use to aspirate bone marrow or autologous blood.
  • 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