Home / Recalls / Medical Devices
EBI, LLC recalls Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acqui
Recalled May 1, 2024 · FDA recall Z-1617-2024 · 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
1412 units ( 2 leads per assembly)
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 OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Manufacturer(s)
EBI, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →