Events

Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Blackstone Medical, 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
    45523
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0363-2008
  • 사례 시작날짜
    2007-05-15
  • 사례 출판 날짜
    2007-12-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65731
  • 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
    Pedicle Screw Spinal System - Product Code MNI
  • 원인
    Manufacturing defect: the saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. the extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. as a consequence, there is a potential for set-screw cross-threading during implantation. cross-threading could in turn lead to a comprom.
  • 조치
    Blackstone Medical, Inc., field representatives were notified via phone, e-mail or fax on 4/30/07. Attention: Notification of Product Removal Letters were sent on May 15, 2007, to distributors and implanting surgeons requesting return of non-implanted stock.

Device

Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
  • 제품 설명
    Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
  • Manufacturer
    Blackstone Medical, Inc.

Manufacturer

Blackstone Medical, Inc.
  • 제조사 주소
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • 제조사 모회사 (2017)
    Orthofix Medical, Inc.
  • Source
    USFDA