Reported Sep 24, 2025 · Ongoing

Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Folsom Metal Products, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Folsom Metal Products, Inc. · 1449 Court Pl · Pelham, AL · 35124-1858

Is this the product you have?

  • Frontier Devices
  • REF
    • 301.912S2
    • 12 mm Distraction Pin
    • 10 double packs
    • Rx Only
    • Sterile
Lot codes and dates
    • All lots distributed from August 1
    • 2020
    • to July 30
    • 2025/UDI: 00850014548070
Amount recalled
160 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Labeling includes shelf life that has not been validated.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.