Recall Z-0540-2026 ยท MQV Filler, Bone Void, Calcium Compound
Berkeley Advanced Biomaterials, LLC
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.
| Date | Nov 18, 2025 (initiated Sep 2, 2025) |
| Status | Open, Classified |
| Reason | Due to incorrect product label (Incorrect product name identified on outer packaging). |
| Root cause | Process control |
| Action | Between 09/02/2025 to 10/21/2025, the firm emailed an "URGENT-MEDICAL DEVICE RECALL" Letter to customers informing then that affected Tribio Implants have incorrect outer box labeling. The product itself is not defective, but the packaging label does not accurately reflect the product name. The issue of incorrect labeling on the packaging relates solely to the product description, which mistakenly lists the item as a 'Resorbable Bead kit' instead of its correct designation, 'Tribio" Implant.' Customers are instructed to: 1. QUARANTINE all affected products immediately. 2. DO NOT USE any impl |
| Quantity | 62 units |
| Distribution | U.S. Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170917 | Bi-Ostetic Bioactive Glass Foam Berkeley Advanced Biomaterials, Oct 30, 2017 |