Device product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
Z-2501-2020
Product summary
- Event
- Event 85218
- Status
- Completed
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-2501-2020
Official wording
Reason: Reports received of the device fracturing during insertion.
Code information: Lot numbers 14LDDOCB, 15CNDOBC, 15DIDOCC, and 7FGAD.
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.