Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # Recalled by Alphatec Spine, Inc. Due to The recall was initiated because Alphatec Spine confirmed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alphatec Spine, Inc. directly.
Affected Products
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Quantity: 11 units
Why Was This Recalled?
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alphatec Spine, Inc.
Alphatec Spine, Inc. has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report