Ebi, LLC FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acClass IIMar 22, 2024Damage to the lead wire sheath (black cable) component and c	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to	Class IIDevices	Mar 22, 2024
20" Lead Wires, Replacement Part Number: 1067724-2Class IIMar 22, 2024Damage to the lead wire sheath (black cable) component and c	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to	Class IIDevices	Mar 22, 2024
48" Lead Wires, Replacement Part Number: 1067724-4Class IIMar 22, 2024Damage to the lead wire sheath (black cable) component and c	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to	Class IIDevices	Mar 22, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquiClass IIMar 22, 2024Damage to the lead wire sheath (black cable) component and c	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to	Class IIDevices	Mar 22, 2024