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Folsom Metal Products, Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, SterileClass IIAug 21, 2025Labeling includes shelf life that has not been validated. |
| Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, SterileClass IIAug 21, 2025Labeling includes shelf life that has not been validated. |
| Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, SterileClass IIAug 21, 2025Labeling includes shelf life that has not been validated. |
| Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, SterileClass IIAug 21, 2025Labeling includes shelf life that has not been validated. |
| Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, SterileClass IIAug 21, 2025Labeling includes shelf life that has not been validated. |
| Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, SterileClass IIAug 21, 2025Labeling includes shelf life that has not been validated. |
| DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) conClass IIOct 30, 2023Units were not intended for commercial distribution and inad |
| Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mClass IIOct 30, 2023Units were not intended for commercial distribution and inad |