Events

LINX Reflux Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Torax Medical, 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
    79822
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2038-2018
  • 사례 시작날짜
    2018-04-20
  • 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=163589
  • 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
    Implant, anti-gastroesophageal reflux - Product Code LEI
  • 원인
    Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. this condition may result in a discontinuous or open linx device.
  • 조치
    The firm, Consignees Torax Medical Inc., sent an "URGENT: FIELD SAFETY NOTICE (REMOVAL)" letter mailed on approximately 04/20/2018 (US consignees and physicians) and 04/23/2018 (OUS consignees and physicians). The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine any affected product, communicate the issue to all relevant operating room or materials management personnel, forward the recall information to facilities where the product may have been forwarded to, complete the Business Reply Form confirming receipt of this notice and return it to Torax Medical, Inc. within three (3) business days via email at brf@toraxmedical.com; ( return the BRF even if you do not have the product lot subject to this recall.), and arrange the return of any affected product on hand. Additionally, a recall notification will be sent to sent to physicians outlining the reason for recall and to advise them to monitor their patients. Question regarding the recall can be directed to the Customer Support Cetner at 1-877-384-4266, which is open Monday through Friday, 7:30 AM to 6:30 PM ET.

Device

LINX Reflux Management System
  • 모델명 / 제조번호(시리얼번호)
    a. Product Code LXC-12, Part No. 3718-12, GTIN 00855106005134;  b. Product Code LXC-13, Part No. 3718-13, GTIN 00855106005141;  c. Product Code LXC-14, Part No. 3718-14, GTIN 00855106005158;  d. Product Code LXC-15, Part No. 3718-15, GTIN 00855106005165;  e. Product Code LXC-16, Part No. 3718-16, GTIN 00855106005172;  f. Product Code LXC-17, Part No. 3718-17, GTIN 00855106005189;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.
  • 제품 설명
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: || a. Product Code LXC-12; || b. Product Code LXC-13; || c. Product Code LXC-14; || d. Product Code LXC-15; || e. Product Code LXC-16; || f. Product Code LXC-17; || Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
  • Manufacturer
    Torax Medical, Inc.

Manufacturer

Torax Medical, Inc.
  • 제조사 주소
    Torax Medical, Inc., 4188 Lexington Ave N, Shoreview MN 55126-6106
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA