Events

Device Recall Screw inserter (screwdriver orthopedic manual surgical instrument) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 SpineFrontier, 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
    64984
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1926-2013
  • 사례 시작날짜
    2013-03-14
  • 사례 출판 날짜
    2013-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117582
  • 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
    screwdriver - Product Code HXX
  • 원인
    Inserters have a set screw that fixes a collar to the inserter. the screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. when the collar is not in place the locking sleeve can also slide off the inserter.
  • 조치
    Spine Frontier sent an email dated December 10, 2012, to the affected customers that a Pedfuse Inserter with part number PM3979 needed to be returned. Further questions please call (978) 232-3990.

Device

Device Recall Screw inserter (screwdriver orthopedic manual surgical instrument)
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: PM3979
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution only in Texas.
  • 제품 설명
    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 || Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • 제조사 주소
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • 제조사 모회사 (2017)
    SpineFrontier, Inc.
  • Source
    USFDA