Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide Recalled by Alphatec Spine, Inc. Due to Alphatec Spine initiated this medical device recall for...
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
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Quantity: 1,814
Why Was This Recalled?
Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
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