Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Polaris 4.75 TI Spinal System Recalled by Biomet Spine, LLC Due to Multiaxial screws may not meet internal requirements related...
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 Biomet Spine, LLC directly.
Affected Products
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
Quantity: 4,765 units
Why Was This Recalled?
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biomet Spine, LLC
Biomet Spine, LLC has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report