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

Recalled November 26, 2025 · FDA recall Z-0540-2026 · Berkeley Advanced Biomaterials

Hazard

Due to incorrect product label (Incorrect product name identified on outer packaging). · FDA Class II

Units

62 units

Sold at

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

Description

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.

Manufacturer(s)

Berkeley Advanced Biomaterials, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →