Events

Illico Ti Cannulated Polyaxial Screw 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alphatec Spine, 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
    63385
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0168-2013
  • 사례 출판 날짜
    2012-10-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113646
  • 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, spondylolisthesis spinal fixation - Product Code MNH
  • 원인
    The firm initiated the recall because the stainless steel guide-wire of the illico mis fixation system did not completely fit/pass through the tip of certain illico ti cannulated polyaxial screws, therefore rendering such screws nonfunctional.
  • 조치
    Alphatec Spine sent an Urgent Medical Device Recall Notification letter dated September 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Alphatec Spine's Customers Service Department (customerservice@alphatecspine.com) immediately for instructions on how to return the affected product. Customers were asked to fill out the lower portion of the letter and fax to (760) 431-0289 to confirm that they have read the notification and will take all necessary removal actions. For questions customers were instructed to call 1-800-922-1356. For questions regarding this recall call 760-431-9286.

Device

Illico Ti Cannulated Polyaxial Screw
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: KW, MNI, MNH.  Part NumberlLot Number: ¿PART DESCRIPTION LOT  7384S-30 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm 646501  73845-35 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm 646502  73845-40 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm 646503  73845-45 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm 646504  73855-35 Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm 646510  73865-30 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm 646515  73865-35 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm 646516  73865-40 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm 646517  73865-45 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm 646542  73865-50 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm 646543  73875-35 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm 646546  73875-45 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm 646548  73875-50 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm 646549
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.
  • 제품 설명
    ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, || Orthosis, Spinal Pedical Fixation || Orthosis, Spondylolisthesis Spinal Fixation || The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • 제조사 주소
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA