Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates the surgic
FDA device recall Z-0932-2012 · posted 2012-01-31 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 27 units
- Distribution
- Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
- Date initiated
- 2010-11-01
- Date posted
- 2012-01-31
- Date terminated
- 2012-01-31
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM (K071380) | Alphatec Spine, Inc. | 2007-08-20 |
| SOLANAS POSTERIOR STABILIZATION SYSTEM (K052201) | Alphatec Spine, Inc. | 2005-11-10 |