Events

Device Recall Concorde Lift 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Orthopaedics, 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
    79072
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0849-2018
  • 사례 시작날짜
    2017-07-26
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161277
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Potential for intra-operative breakage of driver tips.
  • 조치
    On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be forwarded to all staff that need to be informed, as well as, any facility that the affected device was further distributed to. Customers should direct any questions regarding this recall to their DePuy Synthes Spine Sales Consultant or the Clarke Madigan, DePuy Synthes Spine Recall Coordinator, at 508-828-609 or DPYUS-SpineFieldActions@its.jnj.com.

Device

Device Recall Concorde Lift
  • 모델명 / 제조번호(시리얼번호)
    Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Concorde Lift Torque Limiting Handle. || Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

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