Phantom Hindfoot TTC/TC Nail System P31-600-175L-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889795118141), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, 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 ↗