FDA Enforcement
Class II
Ongoing
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
Recall: Z-1617-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1617-2024
- Event ID
- 94291
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- EBI, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2024
- Initiation Date
- March 22, 2024
- Classification Date
- April 23, 2024
- Address
- 1 Gatehall Dr Ste 303, N/A, Parsippany, NJ, 07054-4514, United States
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
Reason
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
Code Info
UD-DI: 00812301020232 All devices distributed since May 1, 2023
Distribution
US Nationwide distribution.
Quantity
1412 units ( 2 leads per assembly)