Events

Sterile Bone Cutting Bur 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
    57933
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2036-2011
  • 사례 출판 날짜
    2011-04-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97849
  • 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
    Burr, orthopedic - Product Code HTT
  • 원인
    Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
  • 조치
    The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.

Device

Sterile Bone Cutting Bur
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
  • 제품 설명
    ***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tele: (800) 327-6887/ + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102. || Intended usage: 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