FDA recall Z-2504-2020
CTL Medical Corporation · Class II · device
Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Reason for recall
Reports received of the device fracturing during insertion.
Distribution
Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Key facts
- Status
- Completed
- Initiation date
- 2019-08-21
- Report date
- 2020-07-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Addison, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2504-2020