Events

Quick Connect Adapter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Orthohelix Surgical Designs 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
    54542
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1399-2010
  • 사례 시작날짜
    2009-10-16
  • 사례 출판 날짜
    2010-04-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88685
  • 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
    The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument. also the adapters have a wobble between the two ends. this is caused when the distal and proximal ends of the adapter assembly were.
  • 조치
    Two "IMPORTANT RECALL NOTICE" letters, one dated October 16, 2009, and the second letter dated November 19, 2009, were sent to the customers. The letters described the product, problem and action to be taken by the customers. The customer are requested to discontinue use of the adapters and return them to the firm, Orthohelix Surgical Designs. The firm will replace the adapters as soon as possible. Should you have any questions about the systems please contact Kristin Wolff at 330-247-1445 or Jim Bragg at 330-247-1444.

Device

Quick Connect Adapter
  • 모델명 / 제조번호(시리얼번호)
    Model #CSS-QA-Adapter Lot #: GB759, GB-924, 1014001 & 1101011
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and WI.
  • 제품 설명
    Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH || The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • 제조사 주소
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • 제조사 모회사 (2017)
    Wright Medical Group NV
  • Source
    USFDA