Berkeley, CA, United States
Berkeley Advanced Biomaterials, LLC recalls
1 recall recorded since 2018, most recently on 2 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 September 2025
- Reason
- Due to incorrect product label (Incorrect product name identified on outer packaging).
- Distribution
- U.S. Nationwide distribution in the state of TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0540-2026
- 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 postero
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.