Pelham, AL, United States
Folsom Metal Products, Inc. recalls
2 recalls recorded since 2018, most recently on 21 August 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 August 2025
- Reason
- Labeling includes shelf life that has not been validated.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2576-2025, Z-2578-2025, Z-2581-2025, Z-2577-2025, Z-2580-2025, Z-2579-2025
- Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
- Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Ongoing Class II Medical devices
- Recall started
- 30 October 2023
- Reason
- Units were not intended for commercial distribution and inadvertently distributed.
- Distribution
- US distribution to KS, LA, MI, NY, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0650-2025, Z-0651-2025
- DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model
- Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.