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EBI, LLC recalls Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion ac
Recalled May 1, 2024 · FDA recall Z-1616-2024 · EBI
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 · FDA Class II
Units
N/A
Sold at
US Nationwide distribution.
Description
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
Product
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
Manufacturer(s)
EBI, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →