Device Recall Collagen Meniscus Implant

  • 모델명 / 제조번호(시리얼번호)
    Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Netherlands
  • 제품 설명
    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant || Product Usage: || The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
  • Source
    USFDA