Panta 2 Arthrodesis Nail System PAN-1010-11180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556829028), received between May 22, 2025 and Feb 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) PANTA NAIL, 11MM DIA. X 180MM WAS FOUND TO BE UNSTERILE UPON OPENING DUE TO DAMAGE WITHIN THE PACKAGING. A CUT WAS OBSERVED EXTENDING COMPLETELY THROUGH BOTH PEEL PACKS, WHILE THE OUTER BOX APPEARED INTACT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428875 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT DID NOT FUSE THE SUBTALAR JOINT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A PANTA NAIL, 11MM DIA. X 180MM, WAS EXCHANGED AND A STRYKER PLATE WAS APPLIED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 22068140 ↗