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FDA (Device enforcement)Recalled 2021-07-30closedclass ii

Paragon 28, Inc.: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

Is my product affected?

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

  • UPC 00889795056849

Check against the official notice below — it lists the full affected range.

What happened

Paragon 28, Inc. is recalling 14 Phantom Nail System drill bits (Model P99-110-4630, Lot Number HN120550) distributed nationwide across 15 U.S. states. The drills have a thin wall condition between the inner cannulation and the flutes that could potentially cause the drill wall to fracture.

The recall notice does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: 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 Quantity: 14 drill bits Lot/code info: Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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