Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is ind…

Recall date

September 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0540-2026

FDA classification

Class II

Brand / firm

Berkeley Advanced Biomaterials, LLC

Sold / distributed

U.S. Nationwide distribution in the state of TN.

Why it was recalled

Due to incorrect product label (Incorrect product name identified on outer packaging).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.