Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008
- Recalling company
- Berkeley Advanced Biomaterials, LLC
- 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
- Due to incorrect product label (Incorrect product name identified on outer packaging).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 2, 2025
- Reported
- Nov 26, 2025
- Distribution
- U.S. Nationwide distribution in the state of TN.
- Status
- Ongoing
- Quantity
- 62 units
- Lot / codes
- Catalog Number: M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Lot Number: EBL10B13C Serial Numbers: EBL10112 - EBL10115 EBL10051-EBL10053, EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109
- Company location
- Berkeley, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0540-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0540-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.