FDAHealthAugust 21, 2025
Folsom Metal Products, Inc. — Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
⚠️ Labeling includes shelf life that has not been validated.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 21, 2025
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
What's affected?
- Product
- Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Lot code
- distributed
Additional details
All lots distributed from August 1, 2020, to July 30, 2025/UDI:00850014548056
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 490 units.
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