Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part… recallZ-0190-2010 · Alphatec Spine, Inc. · initiated May 13, 2009
Terminated All recalls posted in November 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alphatec Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0190-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 13, 2009
- Posted by the FDA
- Nov 12, 2009
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 37 devices
- Product code
- MAX
- FDA submissions
- K080699
- Distribution
- Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
Product description
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.
Code information (models, lots, serial 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.
Other devices under the same FDA submission
2 devices cleared under K080699 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Novel 64813-011Alphatec Spine, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Novel 64918Alphatec Spine, Inc. · Intervertebral fusion device with bone graft, lumbar1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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