FDA-Device2024-05-01Class II
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
EBI, LLC
Hazard
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
Sold states
US Nationwide distribution.
Affected count
N/A
Manufactured in
1 Gatehall Dr Ste 303, N/A, Parsippany, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2024Don't want to check this manually?
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