Events

Device Recall Reprocessed Mitek Arthroscopic Wand 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Sustainability Solutions, 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
    61296
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1204-2012
  • 사례 시작날짜
    2009-06-01
  • 사례 출판 날짜
    2012-03-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107760
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    On 06/09/2009, stryker sustain ability solutions, formerly ascent healthcare solutions, recalled lots 674201 & 674290 of their reprocessed mitek arthroscopic wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09.
  • 조치
    Ascent Healthcare Solutions notified their customers by presenting a letter dated June 1, 2009 from an Ascent Representative. The representative was to recover any products that may have been affected. Questions were directed to 1-888-888-3433.

Device

Device Recall Reprocessed Mitek Arthroscopic Wand
  • 모델명 / 제조번호(시리얼번호)
    Model # 225301 Lot #s: 674201 & 674290 Expiration dates: 04/2012
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA), including the states of: TX, NY, MN, CA, and CT.
  • 제품 설명
    The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions. || The outer box of the Reprocessed Mitek Arthroscopic Wand is labeled in part: "***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***Contents sterile by EO unless package is opened or damaged.***Reprocessed Device for single use. Reprocessed By Ascent Healthcare Solutions.***Cat #: 225301 MITEK 3.5mm SIDE EFFECT ELECTRODE***Lot #: 674290 Expiration Date: 04/2012***" || Individual pouch labeled in part: "***Cat #: 225301***MITEK 3.5mm SIDE EFFECT ELECTRODE****IFU at www.ascenths.com***Contents: One Expiration Date 04/2012***Lot # 674201 ID# 0***Reprocessed by Ascent Healthcare Solutions Not affiliated with the original manufacturer.***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***"
  • Manufacturer
    Stryker Sustainability Solutions, Inc.

Manufacturer

Stryker Sustainability Solutions, Inc.
  • 제조사 주소
    Stryker Sustainability Solutions, Inc., 5307 Great Oak Dr, Lakeland FL 33815-3113
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA