FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0540-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0540-2026
- Event ID
- 97601
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Berkeley Advanced Biomaterials, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 26, 2025
- Initiation Date
- September 2, 2025
- Classification Date
- November 18, 2025
- Address
- 2800 7th St, Berkeley, CA, 94710-2703, United States
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.
Reason
Due to incorrect product label (Incorrect product name identified on outer packaging).
Code Info
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.
Quantity
62 units