Class II
Medical Device Recall: Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Folsom Metal Products, Inc. · August 21, 2025
Reason for Recall
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.
States Affected
NATIONWIDE
Quantity Affected
10,960 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2579-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.