Events

Device Recall Signature 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Materialise USA LLC 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
    67039
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0628-2014
  • 사례 시작날짜
    2013-11-26
  • 사례 출판 날짜
    2014-01-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124626
  • 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
    Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
  • 원인
    Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
  • 조치
    Materialise USA LLC notified the Field Representative on November 26, 2013 of the recall by phone followed by E-mail notification. The notification identified the device and reason for the recall. Notification directions included instructions to find and quarantine the device and return it Materialise. A replacement device was shipped November 27, 2013 receiving the defective device was called, followed by E-mail notification the Recall, which identified the device, problem, and instructed the distributor to find and quarantine product. For questions regarding this recall call 734-662-5057.

Device

Device Recall Signature
  • 모델명 / 제조번호(시리얼번호)
    Lot 094929
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution: MO only.
  • 제품 설명
    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE || SIGNATURE || M PKA GDE/MDL SET SML-MP || DD.....R-FEB55RKA-T JA-A01 05551 || PKA POST CUT SML-PKA MICROPLASTY || CUSTOM-MADE DEVICE || non-sterile || The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
  • Manufacturer
    Materialise USA LLC

Manufacturer

Materialise USA LLC
  • 제조사 주소
    Materialise USA LLC, 44650 Helm Ct, Plymouth MI 48170-6061
  • 제조사 모회사 (2017)
    Materialise Nv
  • Source
    USFDA