FDA recall Z-1617-2024

EBI, LLC · Class II · device

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

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-03-22
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2024