Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the Recalled by EBI, LLC Due to Damage to the lead wire sheath (black cable)...
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 EBI, LLC directly.
Affected Products
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Quantity: N/A
Why Was This Recalled?
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About EBI, LLC
EBI, LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report