Z-2504-2020 Class II
FDA device recall Z-2504-2020 was initiated by CTL Medical Corporation on August 21, 2019 and is designated Class II. Reason for recall: Reports received of the device fracturing during insertion. Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- August 21, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
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 Pattern
Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Code Information
Lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC.