CTL Medical Corporation FDA Record
CTL Medical Corporation has 6 FDA recalls, 3 inspections, 14 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CTL Medical Corporation" is on file.
- Latest recall
- Z-2504-2020 · Class II · Aug 21, 2019
- Latest inspection
- May 1, 2025 · NAI
- Latest 510(k)
- Oct 10, 2024
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 6 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 14 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 4 | 0 |
| 2018 | 1 | 0 | 0 | 2 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2504-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. | Aug 21, 2019 |
| Z-2503-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. | Aug 21, 2019 |
| Z-2501-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. | Aug 21, 2019 |
| Z-2502-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. | Aug 21, 2019 |
| Z-1030-2019 | Class II | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | Jul 5, 2018 |
| Z-1031-2019 | Class II | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 | Jul 5, 2018 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 1, 2025 | Carrollton, TX | Devices | No Action Indicated (NAI) | 3009051471 |
| Jan 18, 2018 | Carrollton, TX | Biologics | No Action Indicated (NAI) | 3009051471 |
| Dec 4, 2013 | Carrollton, TX | Biologics | No Action Indicated (NAI) | 3009051471 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009051471 | Carrollton, TX | 3 | May 1, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Oct 10, 2024 |
| K231715 | MONDRIAN Anterior Lumbar Plate System | Jan 26, 2024 |
| K231359 | RODIN Expandable Lumbar Cage System | Jun 9, 2023 |
| K220513 | NITRO Interbody Fusion Cage System Family | Apr 25, 2023 |
| K220334 | MONET Anterior Cervical Plate System | Nov 9, 2022 |
| K211785 | CASSATT SIJ Fixation System | Oct 17, 2022 |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Sep 15, 2022 |
| K213491 | Universal Pilot Guidance Instrument System | May 12, 2022 |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Aug 26, 2020 |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | Oct 11, 2018 |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage System | Jun 25, 2018 |
| K173185 | SEURAT Universal Pedicle Screw System | Feb 14, 2018 |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK | Jan 9, 2018 |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | Jun 1, 2017 |
CTL Medical Corporation and the FDA: common questions
Has CTL Medical Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "CTL Medical Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has CTL Medical Corporation received an FDA Form 483?
FDA has not published a Form 483 for "CTL Medical Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CTL Medical Corporation?
The most recent FDA inspection on file ended May 1, 2025 at Carrollton, TX and was classified NAI. FDA has 3 inspections of CTL Medical Corporation on file.
Has CTL Medical Corporation had an FDA recall?
Yes. CTL Medical Corporation has 6 FDA recalls on record. The most recent started Aug 21, 2019.
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