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.
Reported: November 26, 2025 Initiated: September 2, 2025 #Z-0540-2026
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).
Details
- Recalling Firm
- Berkeley Advanced Biomaterials, LLC
- Units Affected
- 62 units
- Distribution
- U.S. Nationwide distribution in the state of TN.
- Location
- Berkeley, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Berkeley Advanced Biomaterials, LLC. Units affected: 62 units.
Why was this product recalled? ▼
Due to incorrect product label (Incorrect product name identified on outer packaging).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0540-2026.
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