CTL Medical Corporation FDA Inspection Record
CTL Medical Corporation is an FDA-registered facility (FEI 3009051471) located in Carrollton, TX, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 1, 2025: No Action Indicated (NAI)
- Inspections on record
- 3 (3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Aug 21, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 1, 2025 | No Action Indicated (NAI) | No citations listed |
| Jan 18, 2018 | No Action Indicated (NAI) | No citations listed |
| Dec 4, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 21, 2019 | Class II | Z-2501-2020 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. and 3 more products Reports received of the device fracturing during insertion. |
| Jul 5, 2018 | Class II | Z-1030-2019 | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 and 1 more product the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be… |
Facility details
- Company
- CTL Medical Corporation
- Location
- Carrollton, TX (US)
- Source
- device