Events

SpFPLUS Implantable Stimulator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 EBI Patient Care, Inc. 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
    77089
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2119-2017
  • 사례 시작날짜
    2017-04-20
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155075
  • 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
    Stimulator, invasive bone growth - Product Code LOE
  • 원인
    Zimmer biomet is conducting a medical device field action for the spf plus-mini and spf xl iib implantable spinal fusion stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
  • 조치
    An Urgent Medical Device Recall letter, dated April 20, 2017, was sent to the firm's consignees. The letter identified the affected product and the reason for the recall, as well as the risks involved. Consignees were instructed to quarantine affected product in their inventory and complete the Certification of Acknowledgement portion and the Inventory Return Certification Form in the letter. Affected product must be returned immediately along with the completed Inventory Return Certification Form. Questions or concerns should be directed to the customer call center at 1-800-447-3625 or via email to corporatequality.postmarket@zimmerbiomet.com.

Device

SpFPLUS Implantable Stimulator
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and  410171.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution only.
  • 제품 설명
    10-1398M - SpF-PLUS Implantable Stimulator. || Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
  • Manufacturer
    EBI Patient Care, Inc.

Manufacturer

EBI Patient Care, Inc.
  • 제조사 주소
    EBI Patient Care, Inc., 484 Calle E, Guaynabo PR 00969-3454
  • Source
    USFDA