Alphatec Spine, Inc. Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
Brand
Alphatec Spine, Inc.
Lot Codes / Batch Numbers
Part Number(s): 64817-010 Lot Number(s): 623549, Part Number(s): 64817-012 Lot Number(s): 623551, Part Number(s): 64817-013 Lot Number(s): 623552, Part Number(s): 64817-014 Lot Number(s): 623553, Part Number(s): 64817-107 Lot Number(s): 623584, Part Number(s): 64113-012 Lot Number(s): 623619, Part Number(s): 64113-010 Lot Number(s): 623620, Part Number(s): 64765-109 Lot Number(s): 623909, and Part Number(s): 64733-124 Lot Number(s): 623778.
Products Sold
Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
Alphatec Spine, Inc. is recalling Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 6 due to Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
Recommended Action
Per FDA guidance
Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.
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