Phantom Hindfoot TTC/TC Nail System P31-955-1800-SRecalls & reported problems
Paragon 28, Inc. · Phantom Hindfoot Ball Tipped Guide Rod, 3.0 x 800mm · Class 1
All models of Phantom Hindfoot TTC/TC Nail System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889795061577), received between Dec 9, 2025 and Feb 9, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jun 17, 2026Class IIOpen, Classified
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Z-2758-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Packaging Problem3
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026Packaging Problem
IT WAS REPORTED THAT PACKAGING FOR THREE GUIDE WIRES WERE RECEIVED OPENED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292196 ↗MalfunctionFeb 9, 2026Packaging Problem
IT WAS REPORTED THAT PACKAGING FOR THREE GUIDE WIRES WERE RECEIVED OPENED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292179 ↗MalfunctionFeb 9, 2026Packaging Problem
IT WAS REPORTED THAT PACKAGING FOR THREE GUIDE WIRES WERE RECEIVED OPENED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292173 ↗MalfunctionDec 9, 2025Unsealed Device Packaging; Unsealed Device Packaging
ON AN UNKNOWN DATE, THE GUIDE ROD¿S PACKAGING WAS FOUND OPENED PRIOR TO USE. NO ADDITIONAL DETAILS REGARDING THE CIRCUMSTANCES, PROCEDURE, OR ENVIRONMENT WERE PROVIDED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759258 ↗
Other PASSER, WIRE, ORTHOPEDIC devices
- Guide Wire Kit, 5.5/6.5/7.3 Cannulated Screws GWK 300Flower Orthopedics Corporation · Passer, Wire, Orthopedic1 recall1 report
- Guide Wire Kit, 2.0/2.4 Cannulated Screws GWK 100Flower Orthopedics Corporation · Passer, Wire, Orthopedic2 reports
- Sure-Lok Extended Tab Pedicle Screw System HXI-48-0003Precision Spine, Inc. · Passer, Wire, Orthopedic1 report
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 · each report above links to its original FDA record
- 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.
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