Device product
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.
Z-0540-2026
Product summary
- Event
- Event 97601
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 62 units
- Official record key
device-enforcement:Z-0540-2026
Official wording
Reason: Due to incorrect product label (Incorrect product name identified on outer packaging).
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
Distribution pattern: U.S. Nationwide distribution in the state of TN.
Derived failure modes
-
Labeling or packaging
label (Incorrect