Recall Z-0540-2026— Berkeley Advanced Biomaterials, LLC
Class II · Ongoing
Class II FDA medical device recall by Berkeley Advanced Biomaterials, LLC, initiated 2025-09-02. It names one FDA 510(k) clearance: K170917. 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)..
- Recalling firm
- Berkeley Advanced Biomaterials, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-02
- Firm location
- Berkeley, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Due to incorrect product label (Incorrect product name identified on outer packaging).
Data sourced from openFDA. This site is unofficial and independent of the FDA.