EBI, LLC recalls Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion ac…

Recall date

March 22, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1616-2024

FDA classification

Class II

Brand / firm

EBI, LLC

Sold / distributed

US Nationwide distribution.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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