Device recall
Z-0540-2026: Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10)…
FDA device recall · Class II · Berkeley Advanced Biomaterials, LLC
Key facts
| Recall number (Z-number) | Z-0540-2026 |
|---|---|
| Recall event | 97601 |
| 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… |
| Product code | MQV |
| Recalling firm | Berkeley Advanced Biomaterials, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170917 |
| FEI number | 3014298539 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database