Medical device recalls Moderate risk

Folsom Metal Products, Inc. recalls Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Recall date
August 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2576-2025
FDA classification
Class II
Brand / firm
Folsom Metal Products, Inc.
Sold / distributed
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.

Why it was recalled

Labeling includes shelf life that has not been validated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

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