Recall Z-0932-2012 ยท KWP Appliance, Fixation, Spinal Interlaminal
Alphatec Spine, Inc.
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 thora
| Date | Jan 31, 2012 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 27 units |
| Distribution | Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT. |
| FDA record | Open on fda.gov |