Reported Sep 29, 2021 · Terminated

Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

Paragon 28, 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: Paragon 28, Inc. · 14445 Grasslands Dr · Englewood, CO · 80112-7062

Is this the product you have?

  • Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Lot codes and dates
  • Model NumberP99-110-4630
  • UDI Code(01)00889795056849(10)HN120550
  • Lot NumberHN120550
Amount recalled
14 drill bits

Where it was sold

Why it was recalled

A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.

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

Notice updated Dec 15, 2021 · Data as of Sep 19, 3:33 PM UTC

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