Device Recall JTS External Drive Unit (JTS Grower Drive) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stanmore Implants Worldwide Ltd. 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
    77753
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3104-2017
  • 사례 시작날짜
    2017-07-04
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, constrained, cemented, metal/polymer - Product Code KRO
  • 원인
    Three (3) complaints were identified in which the potential for utilization of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.
  • 조치
    Stanmore Implants sent an Urgent Field Safety Notice dated July 4, 2017, notifying customers of the recall. Additionally, the recalling firm requests that consignees immediately check their inventory for recalled product, quarantine any product on hand, inform SIW of any product on hand, complete the attached response form, and return the response for and affected product to the firm. It is requested that consignees distribute the notice internally to all affected parties and that they contact their local Stanmore representative to request training. If any adverse events are associated with this device, the firm asks that it be reported to them. For further questions, please call (972) 501-1402.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Code MLE3; Serial No. 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 907-028, 907-237, 907-240, 907-500, 907-501, 907-502, 907-503, 907-504.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
  • 제품 설명
    JTS External Drive Unit || JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stanmore Implants Worldwide Ltd., Centennial Park, 210 Centennial Avenue; CENTENNIAL PARK, Borehamwood United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA