Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: Recalled by Berkeley Advanced Biomaterials, LLC Due to Due to incorrect product label (Incorrect product name...

Date: September 2, 2025
Company: Berkeley Advanced Biomaterials, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Berkeley Advanced Biomaterials, LLC directly.

Affected Products

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

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Berkeley Advanced Biomaterials, LLC

Berkeley Advanced Biomaterials, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report