FDA Medical Device Recalls (openFDA)
CTL Medical Corporation: CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
- Recall number
- Z-2502-2020
- Recalling firm
- CTL Medical Corporation
- Product
- CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
- Status
- Completed
- Initiated
- 2019-08-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Reports received of the device fracturing during insertion.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 39 units
- Distribution
- Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
- Lot, serial or model codes
- Lot numbers 14LEDODB, 15CNDOGC, and 15DJDOEC .
- 510(k) numbers
- ["K131981"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3009051471
- Firm city
- Addison
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28