Berkeley Advanced Biomaterials, LLC: 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

Hazard

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

Details from the source

Reason for recall: Due to incorrect product label (Incorrect product name identified on outer packaging). Distribution: U.S. Nationwide distribution in the state of TN. Quantity: 62 units Lot/code info: 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

UPC codes

00816125023653

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.