Class II — Berkeley Advanced Biomaterials, LLC
| Recalling firm | Berkeley Advanced Biomaterials, LLC |
|---|---|
| Registered facility | Berkeley Advanced Biomaterials (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to incorrect product label (Incorrect product name identified on outer packaging). |
| 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. |
| Quantity | 62 units |
| Distribution | U.S. Nationwide distribution in the state of TN. |
| Initiated | 2025-09-02 |
| Classified | 2025-11-18 |
| Recall number | Z-0540-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Berkeley Advanced Biomaterials, LLC (Z-0540-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97601/
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