Events

Spinal Invervetebral Disc Space Orthosis 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Captiva 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
    61925
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1784-2012
  • 사례 시작날짜
    2012-04-27
  • 사례 출판 날짜
    2012-06-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109498
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • 원인
    Captiva spine, inc. initiated a recall of fuselox lumbar implants, trials, and inserters after fda advised the firm that there is inadequate support for implemented design changes to the cleared device pivotec lumbar interbody fusion device.
  • 조치
    Captiva Spine sent a Voluntary Correction Notification letter dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and return affected devices. Customers were also instructed to complete and return a Tracking/Verification Form. For questions customers were instructed to call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

Spinal Invervetebral Disc Space Orthosis
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 07110010 thru 07110016.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide) including FL,TX, UT, and NJ.
  • 제품 설명
    Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***" || FPL - F is FuseLOX, P is Plif, C is Lorditic || Products subject to recall: FuseLOX Lumbar Lorditic: || Lorditic - 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. || Lorditic - 8mm x 25mm Part Number FPL2508 Lot Number 07110011. || Lorditic - 9mm x 25mm Part Number: FPL2509 Lot Number 07110012. || Lorditic - 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. || Lorditic - 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. || Lorditic - 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. || Lorditic - 13mm x 25mm Part Number FPL2513 Lot Number 07110016. || Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. || The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
  • Manufacturer
    Captiva Spine, Inc

Manufacturer

Captiva Spine, Inc
  • 제조사 주소
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • 제조사 모회사 (2017)
    Captiva Spine Inc.
  • Source
    USFDA