FDA-Device2025-09-24Class II

Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.
Hazard

Labeling includes shelf life that has not been validated.

Sold states
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Affected count
2,700 units
Manufactured in
1449 Court Pl, N/A, Pelham, AL, United States
Products
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2578-2025

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