Device Recall Collagen Meniscus Implant

  • Modelo / Serial
    Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Netherlands
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA