Folsom Metal Products, Inc.
FDA Regulatory Profile
Folsom Metal Products, Inc. has 8 FDA recalls, 10 inspections, 1 510(k) clearance and 1 compliance action on record.
- Latest recall
- Z-2579-2025 · Class II · Aug 21, 2025
- Latest inspection
- Aug 1, 2025 · VAI
- Latest 510(k)
- Dec 13, 2010
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 8 | 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 | 10 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2579-2025 | Class II | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile | Aug 21, 2025 |
| Z-2581-2025 | Class II | Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile | Aug 21, 2025 |
| Z-2577-2025 | Class II | Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile | Aug 21, 2025 |
| Z-2578-2025 | Class II | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile | Aug 21, 2025 |
| Z-2580-2025 | Class II | Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile | Aug 21, 2025 |
| Z-2576-2025 | Class II | Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile | Aug 21, 2025 |
| Z-0650-2025 | Class II | DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes… | Oct 30, 2023 |
| Z-0651-2025 | Class II | Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two… | Oct 30, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 1, 2025 | Pelham, AL | Devices | Voluntary Action Indicated (VAI) | 3006803588 |
| Aug 9, 2024 | Pelham, AL | Devices | Voluntary Action Indicated (VAI) | 3006803588 |
| Feb 8, 2022 | Pelham, AL | Biologics | No Action Indicated (NAI) | 3006803588 |
| Nov 13, 2017 | Pelham, AL | Devices | No Action Indicated (NAI) | 3006803588 |
| Oct 17, 2016 | Pelham, AL | Devices | No Action Indicated (NAI) | 3006803588 |
| Mar 3, 2014 | Pelham, AL | Devices | No Action Indicated (NAI) | 3006803588 |
| Apr 25, 2013 | Pelham, AL | Biologics | No Action Indicated (NAI) | 3006803588 |
| Jun 15, 2012 | Pelham, AL | Biologics | No Action Indicated (NAI) | 3006803588 |
| Jun 30, 2010 | Pelham, AL | Devices | No Action Indicated (NAI) | 3006803588 |
| Feb 23, 2009 | Pelham, AL | Devices | Official Action Indicated (OAI) | 3006803588 |
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 3006803588 | Pelham, AL | 10 | Aug 1, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100205 | FRONTIER DEVICES NEURO SYSTEM | Dec 13, 2010 |