FDAFDA · Alimentos y medicamentos·N.º oficial Z-2297-2016
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory 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; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Publicado el 3 de agosto de 2016 · Inicio del retiro: 6 de julio de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smith & Nephew, Inc.
- Distribuidor
- Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR
- Lote
- Lot Number 16AM14274
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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