Berkeley Advanced Biomaterials, LLC: Medical Device Recall in 2025 - (Recall #: Z-0540-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 2, 2025

Date Posted: November 26, 2025

Recall Number: Z-0540-2026

Event ID: 97601

Reason for Recall:

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

Status: Ongoing

Product Quantity: 62 units

Code Information:

Catalog Number: M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Lot Number: EBL10B13C Serial Numbers: EBL10112 - EBL10115 EBL10051-EBL10053, EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated