Events

Device Recall Apex ARC Hip Stem 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Omnilife Science 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
    71407
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2064-2015
  • 사례 시작날짜
    2015-06-03
  • 사례 출판 날짜
    2015-07-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137697
  • 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
    Product may breach the inner and outer sterile pouches during shipping or handling.
  • 조치
    All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to cflores@omnils.com.

Device

Device Recall Apex ARC Hip Stem
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
  • 제품 설명
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA || Product Usage: || The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
  • Manufacturer
    Omnilife Science Inc.

Manufacturer

Omnilife Science Inc.
  • 제조사 주소
    Omnilife Science Inc., 50 Oconnell Way Ste 10, East Taunton MA 02718-1394
  • 제조사 모회사 (2017)
    Omnilife Science Inc
  • Source
    USFDA