Device product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
Z-2503-2020
Product summary
- Event
- Event 85218
- Status
- Completed
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-2503-2020
Official wording
Reason: Reports received of the device fracturing during insertion.
Code information: Lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.
Distribution pattern: Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Derived failure modes
-
Unknown
Reports received of the device fracturing during insertion.