CPM Medical Consultants, LLC.
FDA Regulatory Profile
CPM Medical Consultants, LLC. has 1 FDA recall, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-0230-2026 · Class II · Sep 17, 2025
- Latest inspection
- Aug 29, 2025 · VAI
- Latest 510(k)
- Aug 16, 2021
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0230-2026 | Class II | Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017… | Sep 17, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 29, 2025 | Farmers Branch, TX | Devices | Voluntary Action Indicated (VAI) | 3007334927 |
| Jun 4, 2025 | Farmers Branch, TX | Biologics | No Action Indicated (NAI) | 3007334927 |
| Apr 18, 2018 | Farmers Branch, TX | Biologics | No Action Indicated (NAI) | 3007334927 |
| Dec 20, 2013 | Farmers Branch, TX | Biologics | No Action Indicated (NAI) | 3007334927 |
| Mar 19, 2012 | Farmers Branch, TX | Biologics | Voluntary Action Indicated (VAI) | 3007334927 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3007334927 | Farmers Branch, TX | 5 | Aug 29, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210695 | CPM Medical Consultants Tibial Revision Knee System | Aug 16, 2021 |