Device Recall Modular SMF(TM)

  • Modelo / Serial
    71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4 71352405 SMF STEM RSA SIZE 5 71352406 SMF STEM RSA SIZE 6 71352407 SMF STEM RSA SIZE 7 71352408 SMF STEM RSA SIZE 8 71352409 SMF STEM RSA SIZE 9 71352501 SMF STEM WITH STIKTITE SZ 1 71352502 SMF STEM WITH STIKTITE SZ 2 71352503 SMF STEM WITH STIKTITE SZ 3 71352504 SMF STEM WITH STIKTITE SZ 4 71352505 SMF STEM WITH STIKTITE SZ 5 71352506 SMF STEM WITH STIKTITE SZ 6 71352507 SMF STEM WITH STIKTITE SZ 7 71352508 SMF STEM WITH STIKTITE SZ 8 71352509 SMF STEM WITH STIKTITE SZ 9
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Canada, Switzerland, China, Cyprus, Czech Republic, Dubai, Germany, Denmark, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Mexico, Netherlands, Poland, Puerto Rico, Portugal, Russia, Turkey, and South Africa.
  • Descripción del producto
    Modular SMF(TM) || The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA