Events

Anspach Cutters and Attachments 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Anspach Effort, 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
    67124
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0708-2014
  • 사례 시작날짜
    2012-10-26
  • 사례 출판 날짜
    2014-01-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124743
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • 원인
    During a recent review of documentation anspach determined that the current directions for use for the mca cutting burrs and mca micro curved attachment do not provide clear details regarding the intended use specifically for the mca burrs. the mca burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. the use of the device in dense bone removal may result in cu.
  • 조치
    Anspach sent an Urgent Medical Removal letter dated October 26, 2012, to all affected customers. The letter stated that they were initiating a Medical Device removal regarding the MCA Cutting Burrs. During a recent review of documentation it was determined that the current directions for use for the MCA cutting burrs (item 18-0079) and MCA Micro Curved Attachment (item 18-0060) did not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/ burr fracture. If a fracture occurs, contact Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. If the procedure was done successfully, no additional patient follow up is necessary. Customer Immediate Actions: 1. Please remove and return any MCA items from your inventory immediately. 2. Complete the attached reply form indicating your receipt of this letter. Return the completed form by fax or email to the number or email address provided on the form. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Customers with questions were instructed to contact Anspach Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. For questions regarding this recall call 1-800-327-6887.

Device

Anspach Cutters and Attachments
  • 모델명 / 제조번호(시리얼번호)
    All Lots for  MCA - MICRO CURVED ATTACHMENT,  MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,  MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM,  MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM,  MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM,  MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM,  MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,  MCA5-1SB - lMM FLUTED BALL, 5.6CM,  MCA5-1SD - lMM DIAMOND BALL, 5.6CM,  MCA5-2SB - 2MM FLUTED BALL, 5.6CM,  MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,  MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,  MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,  MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,  MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,  MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,  MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,  MCA7-1SB - lMM FLUTED BALL, 7.3CM,  MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM,  MCA7-2SB - 2MM FLUTED BALL, 7.3CM and  MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
  • 제품 설명
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) || MCA - MICRO CURVED ATTACHMENT, || MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, || MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, || MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, || MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, || MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, || MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, || MCA5-1SB - lMM FLUTED BALL, 5.6CM, || MCA5-1SD - lMM DIAMOND BALL, 5.6CM, || MCA5-2SB - 2MM FLUTED BALL, 5.6CM, || MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, || MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, || MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, || MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, || MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, || MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, || MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, || MCA7-1SB - lMM FLUTED BALL, 7.3CM, || MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, || MCA7-2SB - 2MM FLUTED BALL, 7.3CM and || MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. || The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • 제조사 주소
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA