FDA-Device2024-05-01Class II
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
EBI, LLC
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
Sold states
US Nationwide distribution.
Affected count
1412 units ( 2 leads per assembly)
Manufactured in
1 Gatehall Dr Ste 303, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief