Device Recall Confidence Plus Kit Spinal Cement System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy 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
    79494
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1300-2018
  • 사례 시작날짜
    2017-12-15
  • 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
    Cement, bone, vertebroplasty - Product Code NDN
  • 원인
    Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
  • 조치
    The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The notification described the product, problem and actions to be taken. Notifications were sent to consignees with the following instructions: 1. Immediately identify and quarantine all unused products listed below in a manner that ensures the affected products will not be used. 2. Review, complete, sign and return the attached Business Reply Form to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return any affected product within 30 business days. A credit note will be issued for the returned items. 4. Forward this notice to anyone in your facility that needs to be informed. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. 6. Maintain awareness of this notice until all products listed below have been returned to DePuy Spine. 7. Keep a copy of this notice. If you have questions about this Field Safety Notification, please contact your DePuy Synthes Spine Sales Consultant or the Recall Coordinator via telephone: 1-508-828-6609 or via email: DPYUS-SpineFieldActions@its.jnj.com).

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 129385 129386 133824 133825 133826 133827 133828 133829 133830 133831 134609 134610 134611 134612 134613 134614 135476 135477 135478 145664 145665 145666 145667 145668 145669 145670 145671 147555 152905 152906 152908 153880 153881 153882 153883 153884 153885 153886 153888 153889 154956 154957 HVKBHH HVKBHJ
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
  • 제품 설명
    Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) || The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
  • Manufacturer

Manufacturer

  • 제조사 주소
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • 제조사 모회사 (2017)
  • Source
    USFDA