Events

SmartSet GMV Endurance Gentamicin 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
    66248
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0064-2014
  • 사례 시작날짜
    2013-09-16
  • 사례 출판 날짜
    2013-10-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121889
  • 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
    Bone cement, antibiotic - Product Code MBB
  • 원인
    The smartset¿ gmv endurance gentamicin bone cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the us fda. the intended use stated in the ifu for the smartset¿ gmv endurance gentamicin bone cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia.
  • 조치
    The firm DePuy Synthes, sent an "URGENT INFORMATION-MEDICAL DEVICE RECALL NOTICE" dated September 16, 2013 to its consignees via E-mail, hand delivery or fax depending on the most appropriate delivery method for each consignees. The Urgent recall notice described the recalled product, explained the reason for the recall, and directed consignees to cease further distribution, complete the attached Reconciliation form and quarantine and return all affected products through the DePuy Orthopaedics Sales consultant, Fax 1-787-287-7681 or Email to vbaez1@its.jnj.com. Consignees were directed to maintain a copy of the notice and forward the notice if product was further distributed. Clinical questions should be addressed to DePuy Orthopaedics, Inc's Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). Recall questions or concerns should be addressed to the Quality & Compliance Supervisor, at 1-787- 272-1900 x3114 or vbaez1@its.jnj.com (MF; 8 am- 5 pm EST).

Device

SmartSet GMV Endurance Gentamicin
  • 모델명 / 제조번호(시리얼번호)
    .Lot #s: 1866567 2492886 2844909 3106436 3299572 3434618 F049Z40 1890991 2521804 2866892 3115022 3310546 3466958 1927220 2585596 2888115 3134757 3339992 3475370 1933603 2589374 2889319 3166736 3347549 3483245 1985488 2589379 2981608 3175434 3362229 3498627 2047388 2610503 2991395 3205074 3378764 3528522 2064474 2610505 3011228 3223183 3380098 3572240 2332458 2641279 3042105 3236354 3403313 3572270 2354798 2803352 3062608 3249497 3412748 3590469 2374539 2839097 3078622 3249526 3416122 F024ZA40
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in Puerto Rico and US Virgin Islands.
  • 제품 설명
    SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. || SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA