Events

Device Recall Accell Evo3c Demineralized Bone Matrix Putty 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
    68330
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1868-2014
  • 사례 시작날짜
    2014-05-19
  • 사례 출판 날짜
    2014-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127361
  • 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
    Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
  • 원인
    This lot of accell evo3c demineralized bone matrix, 5cc was incorrectly packaged in boxes that describe the product as accell evo3 demineralized bone matrix. evo3c is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.
  • 조치
    Integra sent an Urgent Voluntary Medical Device Recall dated May 19, 2014 to customers via mail (traceable courier service). The recall notification letter identified affected product, reason for recall and actions to be taken Customers were instructed to complete the "RECALL ACKNOWLEDGEMENT AND RETURN FORM". and return to: FCA1@integralife.com or FAX to 1-609-275-9445. For questions contact Customer Service at 1-800-550-7155.

Device

Device Recall Accell Evo3c Demineralized Bone Matrix Putty
  • 모델명 / 제조번호(시리얼번호)
    Model Number: 02-6000-050 , Lot Number: 132160.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. || Product Usage: || Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.