FDA-Device2025-11-26Class II
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.
Berkeley Advanced Biomaterials, LLC
Hazard
Due to incorrect product label (Incorrect product name identified on outer packaging).
Sold states
U.S. Nationwide distribution in the state of TN.
Affected count
62 units
Manufactured in
2800 7th St, Berkeley, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0540-2026Don't want to check this manually?
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