FDAFDA · Food and drugs·Recall number Z-2576-2025
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Published September 24, 2025 · Recall initiated: August 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling includes shelf life that has not been validated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Folsom Metal Products, Inc.
- Distributor
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
- Lot
- All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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