Recall Z-2504-2020
CTL Medical Corporation · initiated August 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Codes / lots: Lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC.
Reason for recall
Reports received of the device fracturing during insertion.
FDA-determined cause: Device Design
Action taken
The recalling firm issued letters dated 8/21/2019 to all distributors or CTL representatives via email beginning 8/21/2019 with a follow-up hard copy of the correspondence being issued via FedEx. The devices were to be returned.
Details
- Recall number
- Z-2504-2020
- Initiated
- August 21, 2019
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 46 units
- Distribution
- Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
- Recalling firm
- CTL Medical Corporation, Addison, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2501-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.Reports received of the device fracturing during insertion. | 08/21/2019Completed |
| Z-2502-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.Reports received of the device fracturing during insertion. | 08/21/2019Completed |
| Z-2503-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.Reports received of the device fracturing during insertion. | 08/21/2019Completed |