Events

Device Recall Omni Spine Anterior Cervical Plate System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Amendia, Inc dba Spinal Elements 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
    78592
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0239-2018
  • 사례 시작날짜
    2017-11-13
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159848
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • 원인
    Potential incorrect marking and color identification of piranha screw. some screws marked as 12 mm actually measure 14 mm.
  • 조치
    Spinal Elements sent an Urgent Medical Device Recall letter dated November 13, 2017. Instructions included to examine inventory and quarantine affected products, complete and return the response form, arrange for return of any affected product, and to notify customers if further distributed. For further questions, please call (770) 575-5274.

Device

Device Recall Omni Spine Anterior Cervical Plate System
  • 모델명 / 제조번호(시리얼번호)
    Part No. CSF-40-12, Lot No. 132635
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
  • 제품 설명
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System || The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
  • Manufacturer
    Amendia, Inc dba Spinal Elements

Manufacturer

Amendia, Inc dba Spinal Elements
  • 제조사 주소
    Amendia, Inc dba Spinal Elements, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • 제조사 모회사 (2017)
    Spinal Elements
  • Source
    USFDA