Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers :… recallZ-0508-2009 · Alphatec Spine, Inc. · initiated Aug 16, 2007
Terminated All recalls posted in December 2008
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
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
FDA root cause category: Process control
What the company is doing
The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.
Recall details
- Recall number
- Z-0508-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 16, 2007
- Posted by the FDA
- Dec 31, 2008
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 4 units
- Product code
- MQP
- FDA submissions
- K050553
- Distribution
- Nationwide Distribution --- including states of AZ, FL, NY & TX.
Product description
Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
Code information (models, lots, serial numbers)
Lot Number: 611881
Other devices under the same FDA submission
1 device cleared under K050553 — 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 Spinal Spacer System 64813-008Alphatec Spine, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 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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