Events

Device Recall Exogen Express Bone Healing System 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
    52228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1696-2009
  • 사례 시작날짜
    2009-06-05
  • 사례 출판 날짜
    2009-08-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82573
  • 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
    Exogen Express Bone Healing System - Product Code LPQ
  • 원인
    Problems with transducer may result in a reduced ultrasound output.
  • 조치
    All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.

Device

Device Recall Exogen Express Bone Healing System
  • 모델명 / 제조번호(시리얼번호)
    Part number 71034200 (system), Serial numbers: 0408017701, 0408017702, 0408017703, 0408017704, 0408017705, 0408017706, 0408017707, 0408017708, 0408017709, 0408017710, 0408017711, 0408017712, 0408017713, 0408017714, 0408017715, 0408017716, 0408017717, 0408017718, 0408017719, 0408017720, 0408017721, 0408017722, 0408017723, 0408017724, 0408017725, 0408017726, 0408017727, 0408017728, 0408017729, 0408017730, 0408017731, 0408017732, 0408017733, 0408017734, 0408017735, 0408017736, 0408017737, 0408017738, 0408017739, 0408017740, 0408017741, 0408017742, 0408017743, 0408017744, 0408017745, 0408017746, 0408017747, 0408017748, 0408017749, 0408017750, 0109000456, 0109000457, 0109000458, 0109000459, 0109000461, 0109000485, 0109000495 and 0109000496 and  Exogen Express Part number 71034140 (device only), Serial numbers: 0408017129, 0408017132, 0408017133, 0408017138, 0408017147, 0408017155, 0408017157, 0408017158, 0408017161, 0408017162, 0408017168, 0408017171, 0408017175, 0408017178, 0408017184, 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  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
  • 제품 설명
    Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. || The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

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