Alphatec Spine, Inc. Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
Brand
Alphatec Spine, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 624239, 624240
Products Sold
Lot Numbers: 624239, 624240
Alphatec Spine, Inc. is recalling Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026