Berkeley Advanced Biomaterials, LLC: Device Recall
Recall #Z-0540-2026 · 09/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0540-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Berkeley Advanced Biomaterials, LLC
- Status
- Ongoing
- Date Initiated
- 09/02/2025
- Location
- Berkeley, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
Reason for Recall
Due to incorrect product label (Incorrect product name identified on outer packaging).
Product Description
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.
Distribution Pattern
U.S. Nationwide distribution in the state of TN.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.