CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report

Phantom Nail System, Drill, 4.6, Cannulated, 3/16" Sq recalled

Paragon 28 is recalling Phantom Nail System, Drill, 4.6, Cannulated, 3/16" Sq. Connection p28 P99-110-4630, distributed nationwide in the US. The recall was initiated on 30 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550

Quantity recalled14 drill bits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2488-2021
FDA event ID: 88553
Recalling firm: Paragon 28, Englewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2021
FDA classified: 17 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

30 Jul 2021	Recall initiated by company
17 Sep 2021	Classified by FDA	+49 days
29 Sep 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A

Nationwide California Florida Georgia Idaho Kansas Kentucky Louisiana Michigan Missouri North Carolina New York Texas Virginia Washington West Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550

Where was it sold?

U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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