United StatesThe Tribio Implant 7.5mm x 40mm (REF M80 SB008, UDI (01)00816125023653(10)EBL10B13C(17)270630; Lot EBL10B13C; serial numbers EBL10112–EBL10115, EBL10051–EBL10053, EBL10055–EBL10058, EBL10064–EBL10073, EBL10075–EBL10109) indicated for bony voids or gaps is being recalled. The recall was initiated because the outer packaging identifies an incorrect product name; affected units were distributed in Tennessee, U.S.
What's being 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.
Recalling firm: Berkeley Advanced Biomaterials, LLC, Berkeley, CA, United States.
How to identify it
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
The hazard
Due to incorrect product label (Incorrect product name identified on outer packaging).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the state of TN.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)