Phantom Hindfoot TTC/TC Nail SystemRecalls & reported problems across all models
Paragon 28, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Phantom Hindfoot TTC/TC Nail System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of Phantom Hindfoot TTC/TC Nail System by Paragon 28, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2025 and Jun 5, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (3 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Phantom Hindfoot TTC/TC Nail System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 17, 2026Open, 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 ↗
- Jul 30, 2021Terminated
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 ↗
Most reported Phantom Hindfoot TTC/TC Nail System problems
Device problems
- Packaging Problem3
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Phantom Hindfoot TTC/TC Nail System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Phantom Hindfoot TTC/TC Nail System P31-955-1800-SPASSER, WIRE, ORTHOPEDIC1 recall4 reports
- 1 recall0 reports
- Phantom Hindfoot TTC/TC Nail System P31-600-175L-SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent Phantom Hindfoot TTC/TC Nail System adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING A PROCEDURE, THE STERILE BARRIER FOR A NAIL WAS FOUND COMPROMISED UPON OPENING, THE DEVICE WAS CONSIDERED NON-STERILE, AND A DIFFERENT SIZE WAS USED, RESULTING IN A CASE DELAY. AFTER REMOVAL OF THE OUTER PLASTIC WRAP AND DURING OPENING OF THE BOX, THE STERILE WRAP WAS NOTED TO BE ALREADY BROKEN. THE NON-STERILE NAIL WAS NOT USED, AND THE SURGICAL TEAM PROCEEDED WITH A DIFFERENT SIZE IMPLANT, WHICH EXTENDED THE PROCEDURE TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410643 ↗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 Paragon 28, Inc. products
All Paragon 28, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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