Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
This recall has been terminated (originally issued December 14, 2009).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- August 5, 2009
- Posted
- December 14, 2009
- Terminated
- June 7, 2010
- Recall Number
- Z-0503-2010
- Quantity
- 158 units
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution.
Lot / Code Info
Lot Numbers: 624241, 624242, 625418
Root 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.