FDA Device recall Z-1617-2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to tra…
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to tra… by Ebi, citing 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, an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1617-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-22 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ebi |
| Distribution | US |
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
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
Identifiers
| code_info | UD-DI: 00812301020232 All devices distributed since May 1, 2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1617-2024%22
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