Paragon 28, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2488-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 30, 2021

Date Posted: September 29, 2021

Recall Number: Z-2488-2021

Event ID: 88553

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.

Status: Terminated

Product Quantity: 14 drill bits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated