Events

Device Recall Disposable Drill Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ad-Tech Medical Instrument Corporation 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
    80002
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1938-2018
  • 사례 시작날짜
    2017-12-20
  • 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=164195
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    There is a possibility that ddk2-2.4-30x disposable drill kits, lot number 111664 208140649 contained 2.8mm drill bits from ddk2-2.8-30x disposable drill kits, lot number 111745 208140649 and vice versa.
  • 조치
    The firm, Ad-Tech Medical Instrument Corporation, sent a "MEDICAL DEVICE RECALL" letter on approximately 12/20/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine inventory and quarantine any affected product on hand; notify customers of the recall if affected product was further distributed; complete and return the Acknowledgement and Receipt Form via Fax to: 262-634-5668, Attention Customer Support; Mail to: AD-TECH MEDICAL INSTRUMENT CORPORATION, 1901 WILLIAM STREET, RACINE, WI 53404 or Email to: customersupport@adtechmedical.com, and contact an Ad-Tech Customer Support Specialist for a Return Material Authorization (RMA) number. If you have any further questions, contact Regulatory Team Representative and CAPA/Complaints Manager, Monday through Friday, 7:00 AM to 5:00 PM, Central Time via FAX: 262-634-5668, Toll Free: 1-800-776-1555 or Email: customersupport@adtechmedical.com.

Device

Device Recall Disposable Drill Kit
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. DDK2-2.4-30X, Lot No. 0111664 208140649, UDI No. 01008418231011741719080110011174 5208140649;   Catalog No. DDK2-2.8-30X, Lot No. 0111745 208140649, UDI No. 01008418231011671719080110011166 4208140649
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: CA, DC, FL, MI, MA, NC, NY, WA, WI; and country of: Canada. Distributed internationally to the United Kingdom.
  • 제품 설명
    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. || Used to drill cranial holes using a stereotactic frame.
  • Manufacturer
    Ad-Tech Medical Instrument Corporation

Manufacturer

Ad-Tech Medical Instrument Corporation