Events

Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Spine LLC (formerly Kyphon 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
    58425
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3175-2011
  • 사례 시작날짜
    2011-03-23
  • 사례 출판 날짜
    2011-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99328
  • 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
    Arthroscope - Product Code HRX
  • 원인
    Device was shipped past the labeled expiration date.
  • 조치
    On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.

Device

Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0001653390
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA || Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
  • Manufacturer
    Medtronic Spine LLC (formerly Kyphon Inc.)

Manufacturer

Medtronic Spine LLC (formerly Kyphon Inc.)
  • 제조사 주소
    Medtronic Spine LLC (formerly Kyphon Inc.), 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA