Device product
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Z-1067-2024
Product summary
- Event
- Event 93853
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-1067-2024
Official wording
Reason: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Code information: UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Distribution pattern: Product was distributed to Minnesota.
Derived failure modes
-
Unknown
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.