FDAFDA · Alimentos y medicamentos·N.º oficial Z-2677-2014
Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).
Publicado el 1 de octubre de 2014 · Inicio del retiro: 2 de abril de 2014
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 recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Genesys Orthopedics Systems, LLC
- Distribuidor
- Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
- Lote
- The devices being recalled have a catalog number of G826 and a lot number of 11406.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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