Phantom Hindfoot TTC/TC Nail System P99-110-4630Recalls & reported problems

Paragon 28, Inc. · Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection · Class 1

All models of Phantom Hindfoot TTC/TC Nail System (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jul 30, 2021Class IITerminated
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.
Z-2488-2021 · Root cause: Process change control · Recall details · FDA record ↗

Device details

UDI-DI	`00889795056849`
Brand	Phantom Hindfoot TTC/TC Nail System
Model	P99-110-4630
Company	Paragon 28, Inc.
Product code	HTW · BIT, DRILL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Apr 22, 2025

Device type (GMDN): Cannulated surgical drill bit, single-use

A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Other BIT, DRILL devices

QUICKSET 2274-25-500
Depuy Orthopaedics, Inc. · BIT, DRILL
1,985 reports
QUICKSET 2274-35-500
Depuy Orthopaedics, Inc. · BIT, DRILL
770 reports
QUICKSET 2274-30-500
Depuy Orthopaedics, Inc. · BIT, DRILL
761 reports
NA 03.037.022
Synthes GmbH · BIT, DRILL
339 reports
NA 323.062
Synthes GmbH · BIT, DRILL
309 reports
QUICKSET 2274-56-000
Depuy (Ireland) · BIT, DRILL
275 reports
QUICKSET 2274-45-500
Depuy Orthopaedics, Inc. · BIT, DRILL
211 reports
LCS 2366-83-000
Depuy (Ireland) · BIT, DRILL
207 reports

All BIT, DRILL devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page