Events

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Howmedica Osteonics Corp. 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
    79147
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0810-2018
  • 사례 시작날짜
    2017-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161444
  • 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
    When the lever of the insertion handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
  • 조치
    A recall letter, dated August 25, 2017, titled "Product Recall Re: AccuLIFTL Insertion Handle" instructing customers to meet with the Stryker Representative issuing the letter, complete the requested form and return any affected product to this representative. Questions or concerns can be directed to Customer Service at 201-749-8699

Device

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • 모델명 / 제조번호(시리얼번호)
    Model# 800804 Lot numbers 160010 and 170003
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationally
  • 제품 설명
    AccuLIF TL Insertion Handle || The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

Howmedica Osteonics Corp.
  • 제조사 주소
    Howmedica Osteonics Corp., 2 Pearl Ct, Allendale NJ 07401-1611
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA