Events

Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, 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
    77827
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3100-2017
  • 사례 시작날짜
    2017-07-24
  • 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=157987
  • 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, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • 원인
    The cardan joint of the polarstem cardan could potentially fracture or functionally fail after multiple procedures.
  • 조치
    Smith & Nephew sent an Urgent Medical Device Recall Notice dated July 24, 2017, to all affected consignees. The firm notified their consignees by email and Fed Ex on 07/24/2017. Consignees have been asked to inspect inventory to locate and quarantine affected product. All consignees were asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew. Customers with questions were instructed to contact FieldActions@smith-nephew.com. For questions regarding this recall call 978-749-1440.

Device

Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar)
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
  • 제품 설명
    smith&nephew; POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only || The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA