FDA Medical devices recall ·
Tribio Implant 7.5mm x 40mm recall
- Recall number
- Z-0540-2026
- Date
- (initiated September 2, 2025)
- Company / brand
- Berkeley Advanced Biomaterials, LLC
2800 7th St, Berkeley, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 62 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to incorrect product label (Incorrect product name identified on outer packaging).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide distribution in the state of TN.
States: Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0540-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.