Devices

Device Recall Solanas Posterior Stabilization System

Model / Serial
Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
Product Description
Solanas Posterior Stabilization System Part Number: 63920. || Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Manufacturer
Alphatec Spine, Inc.
1 Event
- Recall of Device Recall Solanas Posterior Stabilization System

Manufacturer

Alphatec Spine, Inc.

Manufacturer Address
Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
Manufacturer Parent Company (2017)
Alphatec Holdings Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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