Medical Device Recall: 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:
EBI, LLC · March 22, 2024
Reason for Recall
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 Description
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
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
1412 units ( 2 leads per assembly)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1617-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.