Z-0932-2012

Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates...

Name: Z-0932-2012 Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates...
Creator: Alphatec Spine, Inc.
Published: 2010-11-01
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2010-11-01 / Terminated / root cause: design

FDA source

Alphatec Spine, Inc. began a recall of Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by... on 2010-11-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0932-2012
Status: Terminated
Initiated: 2010-11-01
Posted: 2012-01-31
Terminated: 2012-01-31
Recalling firm: Alphatec Spine, Inc.
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).
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: design
FDA 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 in commerce: 27 units
Distribution: Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
Product codes and lots: Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B

Product code KWP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)