Solanas Posterior Stabilization System Part Number: 63920…

Date posted by the FDA

Jan. 31, 2012

Status

Terminated

Filed by

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).

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.

Distribution pattern

Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.

Quantity

27 units

Codes and lots

Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B

Recall started

Nov. 1, 2010

Device type

Appliance, Fixation, Spinal Interlaminal

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-0932-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0932-2012. The agency record governs; check it and the company before acting.