EBI, LLC: Medical Device Recall in 2024 - (Recall #: Z-1617-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 22, 2024

Date Posted: May 1, 2024

Recall Number: Z-1617-2024

Event ID: 94291

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

Status: Ongoing

Product Quantity: 1412 units ( 2 leads per assembly)

Code Information:

UD-DI: 00812301020232 All devices distributed since May 1, 2023

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated