Biomet SpinalPak Non-invasive Spine Fusion Stimulator System-… — Class II medical device recall Z-1616-2024
Ongoing recall by EBI, LLC, reported 2024-05-01, distributed nationwide. Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to
| Recall number | Z-1616-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | EBI, LLC, Parsippany, NJ, United States |
| Recall initiated | 2024-03-22 |
| Classified | 2024-04-23 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00812301020218 |
| Model numbers | 1067716 |
Product
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1616-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.