Events

Device Recall DePuy Sigma LCS 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
    73076
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0787-2016
  • 사례 시작날짜
    2016-01-08
  • 사례 출판 날짜
    2016-02-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143015
  • 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
    Punch, surgical - Product Code LRY
  • 원인
    Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. this may cause the surgeon to select an insert that is too thin. surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. insert dislocation or spin out, or poor joint mechanics may result, if not noted during surgery. may require revision surgery.
  • 조치
    On 1/8/2016, URGENT INFORMATION  RECALL NOTICE for Specific Lots of SIGMA¿ High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.  5 p.m. EDT). For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT).

Device

Device Recall DePuy Sigma LCS
  • 모델명 / 제조번호(시리얼번호)
    Cat. No. GTIN Lot Description  950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5  950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3  950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7  950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3  950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7  950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.
  • 제품 설명
    SIGMA HP MBT Non-Keel Punch Knee Instrument. || Designed to be used as an option in stabilizing the tibial trial during trial reduction.
  • 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