Recall Z-0503-2010
Alphatec Spine, Inc. · initiated August 5, 2009
Product
Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
Codes / lots: Lot Numbers: 624241, 624242, 625418
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0503-2010
- Initiated
- August 5, 2009
- Posted by FDA
- December 14, 2009
- Terminated
- June 7, 2010
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 158 units
- Distribution
- Nationwide distribution.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0502-2010 | Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body… | 08/05/2009Terminated |