Tribio Implant 7 — Class II medical device recall Z-0540-2026
Ongoing recall by Berkeley Advanced Biomaterials, LLC, reported 2025-11-26, distributed nationwide. Due to incorrect product label (Incorrect product name identified on outer packaging).
| Recall number | Z-0540-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Berkeley Advanced Biomaterials, LLC, Berkeley, CA, United States |
| Recall initiated | 2025-09-02 |
| Classified | 2025-11-18 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 62 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00816125023653 |
| Lot numbers | EBL10B13C |
| Serial numbers | EBL10051-EBL10053, EBL10055-EBL10058, EBL10064, EBL10073, EBL10075, EBL10109, EBL10112, EBL10115 |
| Model numbers | M80, SB008 |
Product
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
Reason for recall
Due to incorrect product label (Incorrect product name identified on outer packaging).
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-0540-2026. 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.