Z-0540-2026 Class II Ongoing
FDA device recall Z-0540-2026 was initiated by Berkeley Advanced Biomaterials, LLC on Sep 2, 2025 and is designated Class II. Reason for recall: Due to incorrect product label (Incorrect product name identified on outer packaging). The recall status is ongoing. Affected quantity: 62 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 26, 2025
- Initiation Date
- Sep 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
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.
Reason for recall
Due to incorrect product label (Incorrect product name identified on outer packaging).
Distribution pattern
U.S. Nationwide distribution in the state of TN.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0540-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026