Events

Novel VBR Spinal System 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
    48177
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0508-2009
  • 사례 시작날짜
    2007-08-16
  • 사례 출판 날짜
    2008-12-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-01-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74679
  • 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
    Spinal Vertebral Body Replacement Device - Product Code MQP
  • 원인
    Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. they were incorrectly laser marked with the wrong part numbers and sizes. two lots were mixed from the following lot numbers: part number 64733-120 lot number 611884, and part number 64753-126 and lot number 611881.
  • 조치
    The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.

Device

Novel VBR Spinal System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 611881
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution --- including states of AZ, FL, NY & TX.
  • 제품 설명
    Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. || Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • 제조사 주소
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • 제조사 모회사 (2017)
    Alphatec Spine Inc
  • Source
    USFDA