Events

Device Recall THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences 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
    58179
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2202-2011
  • 사례 시작날짜
    2011-01-18
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98602
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • 원인
    Certain theken spine vertebral body replacement systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.
  • 조치
    The firm, Integra Spine, sent an "URGENT: RECALL NOTIFICATION" letter dated January 18, 2011, to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their current inventory and return all remaining kits; complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via fax to: 877-558-6227 or email: melissa.niosi@integralife.com, and contact Integra Spine Customer Service at 866-942-8698 regarding availability of suitable replacement products. Integra Spine will be taking immediate action to restore your inventory and ensure minimal impact on availability for surgical procedures. Should you have any additional questions, please feel free to contact me at 609-936-2495 or email at jon.caparotta@integralife.com.

Device

Device Recall THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Vu C POD VBR Kit Identification: 11-001 thru 11-123, 11-026 thru 11-032, 11-034 thru 11-042, 11-044, thru11-048, 11-051 thru 11-058, 11-060, 11-061, 11-062, 11-066 thru 11-072, 11-074 thru 11-087, & 11-102. Ti C POD VBR Kit Identification number: 04-017. Ti L POD VBR Kit Identification numbers: 05-004, 05-006, 05-008, 05-017, 05-023, 05-101, 05-103, 05-107, 05-108, 05-109, 05-112, 05-113, 05-115, 05-123 & 05-124.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: USA including states of: AL, AZ, CA, FL, ID, IL, MD, MI, NH, NM, NV, OH, OK, OR, PA, TX, UT and WI.
  • 제품 설명
    Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima¿ Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement System || The Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.The Theken Vu C POD VBR System is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.