Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
FDA device recall Z-0503-2010 · posted 2009-12-14 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
- Action taken
- Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 158 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-08-05
- Date posted
- 2009-12-14
- Date terminated
- 2010-06-07
- 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 |