FDA recall Z-0540-2026

Berkeley Advanced Biomaterials, LLC · Class II · device

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 for recall

Due to incorrect product label (Incorrect product name identified on outer packaging).

Distribution

U.S. Nationwide distribution in the state of TN.

Key facts

Status
Ongoing
Initiation date
2025-09-02
Report date
2025-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Berkeley, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0540-2026