Events

Device Recall First Choice Partial Ulnar Head System ("DRUJ System"). 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ascension Orthopedics, 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
    60855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1060-2012
  • 사례 시작날짜
    2011-12-03
  • 사례 출판 날짜
    2012-02-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106650
  • 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
    Prosthesis, wrist, hemi-, ulnar - Product Code KXE
  • 원인
    A recent review conducted by ascension orthopedics revealed that certain modifications were made to the first choice system and should have been preceded by a submission of a filing with the fda.
  • 조치
    The Firm, Ascension Orthopedics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 3, 2011 via FedEx, email or fax to all customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately cease any further use of any affected product; remove from their stockrooms until it is shipped back to Ascension Orthopedics; promptly return any affected product to: Ascension Orthopedics, 8700 Cameron Road, Austin, TX 78754, Attn: First Choice DRUJ Recall Administrator, and complete and return the reply form even if you do not have affected product in stock, to Regulatory Affairs Dept. via fax to 512-836-6933. If you have any questions, please do not hesitate to contact customer service at 1-512-836-5001.

Device

Device Recall First Choice Partial Ulnar Head System ("DRUJ System").
  • 모델명 / 제조번호(시리얼번호)
    This recall applies to all of the First Choice DRUJ Partial Ulnar Head Devices. All lot numbers of the following Catalog Numbers are included:  DRUJ-610-1445-WW, DRUJ-610-1455-WW, DRUJ-610-1465-WW,  DRUJ-610-1645-WW,  DRUJ-610-1655-WW,  DRUJ-610-1665-WW,  DRUJ-610-1745-WW,  DRUJ-610-1755-WW,  DRUJ-610-1765-WW,  DRUJ-610-1945-WW,  DRUJ-610-1955-WW, and  DRUJ-610-1965-WW.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution.
  • 제품 설명
    Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. || The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis
  • Manufacturer
    Ascension Orthopedics, Inc

Manufacturer

Ascension Orthopedics, Inc