Events

Device Recall Anspach Single Use, Sterile Bone Cutting Burs 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.

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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
    59182
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3203-2011
  • 사례 시작날짜
    2011-03-17
  • 사례 출판 날짜
    2011-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101910
  • 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
    Motor, drill, electric - Product Code HBC
  • 원인
    The anspach effort, palm beach gardens, fl, is recalling their single use, sterile bone cutting burrs, catalog #, s-1504td, lot #s d363039140. d323038110, d293037349 and catalog # turq-434-4, lot #s d343038845, d323038131, due to the burr being 2.0 mm longer than stated on the label. as a result, a hole drilled using this burr would be 2 mm deeper than the screw.
  • 조치
    Anspach Effort, Palm Beach Gardens, FL sent a Customer letter dated March 31, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to screen their inventory, contact Anspach Customer Support at (800) 327-6887 if any of the recalled product was found, and complete and return the attached reply form. If the product had been further distributed, they were asked that the recall information be forwarded as appropriate.

Device

Device Recall Anspach Single Use, Sterile Bone Cutting Burs
  • 모델명 / 제조번호(시리얼번호)
    Lot #s, D343038845, D323038131
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.
  • 제품 설명
    Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with B-TURQUOISE Attachment.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***" || Cutting and shaping bone including bones of the spine and cranium.
  • 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