Events

Device Recall Poly Component Trial, CR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Sofamor Danek USA 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
    76694
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1515-2017
  • 사례 시작날짜
    2017-02-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153924
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
  • 조치
    Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.

Device

Device Recall Poly Component Trial, CR
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: a) REF 90-SRK-160310, TU53730-01 b) REF 90-SRK-160312, TU53731-01 c) REF 90-SRK-160314, TU53732-01 d) REF 90-SRK-160410, TU53730-02 e) REF 90-SRK-160412, TU53731-02 f) REF 90-SRK-160414, TU53732-02 g) REF 90-SRK-160510, TU53730-03 h) REF 90-SRK-160512, TU53731-03 i) REF 90-SRK-160514, TU53732-03 j) REF 90-SRK-160610, TU53730-04 k) REF 90-SRK-160612, TU53731-04 l) REF 90-SRK-160614, TU53732-04
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US distribution to AR, MA
  • 제품 설명
    Poly Component Trial, CR, packaged in the following sizes and configurations: || a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 || b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 || c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 || d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 || e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 || f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 || g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 || h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 || i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 || j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 || k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 || l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 || The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • 제조사 주소
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • 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