Recall Z-0932-2012
Alphatec Spine, Inc. · initiated November 1, 2010
Product
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).
Codes / lots: Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B
Reason for recall
These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips.
FDA-determined cause: Device Design
Action taken
Alphatec Spine contacted all affected customers via telephone. The communication included discussion of the product, problem, and actions to be taken by the customers. Customers were instructed to remove the affected product from inventory and to return the product to the firm. Arrangements were made for replacement product to be sent to the customers. Contact the firm at 1-800-922-1356 for questions regarding this recall.
Details
- Recall number
- Z-0932-2012
- Initiated
- November 1, 2010
- Posted by FDA
- January 31, 2012
- Terminated
- January 31, 2012
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 27 units
- Distribution
- Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA