Events

Device Recall ROC Lumbar bolt caddy 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alphatec Spine, 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
    52760
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0036-2010
  • 사례 시작날짜
    2008-12-16
  • 사례 출판 날짜
    2009-10-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-11-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83899
  • 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
    Surgical Tray - Product Code LRP
  • 원인
    Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. the actual roc bolts themselves are correctly laser etched.
  • 조치
    Alphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up. Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.) If they have any follow up questions, they were told to call 1-800-922-1356.

Device

Device Recall ROC Lumbar bolt caddy
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 53298
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including states of TX, FL, & NJ.
  • 제품 설명
    ROC Lumbar bolt caddy, Part Number: 81997-01-05. || Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • 제조사 주소
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA