Reported Nov 26, 2025 · Ongoing
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is…
Berkeley Advanced Biomaterials, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Berkeley Advanced Biomaterials, LLC · 2800 7th St · Berkeley, CA · 94710-2703
Is this the product you have?
- 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
- Lot codes and dates
- Catalog NumberM80
- SB008 UDI code(01) 00816125023653(10)
- EBL10B13C(17) 270630 Lot NumberEBL10B13C
- Serial NumbersEBL10112 - EBL10115 EBL10051-EBL10053, EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109
- Amount recalled
- 62 units
Where it was sold
- Nationwide
- TN
Why it was recalled
Due to incorrect product label (Incorrect product name identified on outer packaging).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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