Events

The TiLock Pedicle Screw System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Genesys Orthopedics Systems, LLC 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
    67900
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2677-2014
  • 사례 시작날짜
    2014-04-02
  • 사례 출판 날짜
    2014-09-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126582
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • 원인
    The recall is being initiated because mk precision (the circular lock screw supplier) notified genesys spine that a portion (less than 20%) of the circular lock screws in lot 11406 were manufactured using stainless steel in the center post instead of the specified titanium alloy.
  • 조치
    Genesys Spine sent an Urgent Medical Device Recall letter dated April 2, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Customers were instructed to notify their customers (end users) of the recall and request that they return any affected product to Genesys Spine by completing the attached Recall Tracking Form to Genesys Spine, 1250 South Capital of Texas Hwy, Building Three, Suite 600, Austin, Texas 78746. Customers with questions were instructed to call 512-381-7070.

Device

The TiLock Pedicle Screw System
  • 모델명 / 제조번호(시리얼번호)
    The devices being recalled have a catalog number of G826 and a lot number of 11406.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
  • 제품 설명
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. || The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).
  • Manufacturer
    Genesys Orthopedics Systems, LLC

Manufacturer

Genesys Orthopedics Systems, LLC
  • 제조사 주소
    Genesys Orthopedics Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • 제조사 모회사 (2017)
    Genesys Orthopedics Systems LLC
  • Source
    USFDA