SMART TOE ST0-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252263340), received between Oct 22, 2023 and Feb 9, 2026 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 28, 2022Open, Classified

   The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".

   Z-1011-2022 · Root cause: Process control · FDA record ↗

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.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A HISTORY OF MULTIPLE LEFT FOOT SURGERIES INVOLVING THE TOE ADJACENT TO THE GREAT TOE, INCLUDING TWO REVISION PROCEDURES. THE PATIENT STATED THE SMART TOE IMPLANT APPEARS CROOKED, AND THE TOE INTERMITTENTLY BENDS AND BECOMES STUCK. THE PATIENT DESCRIBED THE CONDITION AS PAINFUL, CAUSING DIFFICULTY WALKING, REQUIRING FLAT-FOOTED AMBULATION, AND RESULTING IN PAIN WITH PRESSURE DURING WALKING.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Joint Impingement; Pain

  MAUDE report 24299101 ↗
• InjuryOct 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17982352 ↗