SMART TOE ST0A-16PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252263418), received between Jun 3, 2020 and Sep 23, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE REP: "IMPLANTS EXPANDED IMMEDIATELY AFTER TAKING OUT FROM THE PACKAGING SO THE IMPLANT COULD NOT BE INSERTED." THE CUSTOMER CONFIRMED THAT THE IMPLANTS WERE STORED AT 0 DEGREES CELSIUS, OR BELOW, FOR A MINIMUM OF 2 HOURS BEFORE THE PROCEDURE AND WERE ONLY REMOVED FROM COLD STORAGE AT THE TIME OF IMPLANTING, AND NOT PRIOR. THE SURGEON HAD TO SWITCH TO INSERTING A TEMPORARY GUIDEWIRE TO TREAT THE PATIENT¿S HAMMERTOE. THIS WAS DIFFERENT TO WHAT WAS PLANNED BUT WAS THE ONLY WAY TO STABILIZE THE JOINT.

  Patient problems: Insufficient Information

  MAUDE report 20286294 ↗
• InjuryApr 4, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE IMPLANT SNAPPED/BROKE AND IS PROTRUDING TO THE SIDE OF HER TOE AND SHE WILL NEED A REVISION. PATIENT IS VERY WORRIED ABOUT GOING IN AND THEY HAVE NOT SEEN ANY PHYSICIANS YET. PATIENT NOTICED THIS BREAKAGE A YEAR OR TWO AGO. PATIENT STARTED NOTICING DISCOMFORT AND PROTRUDING OF IMPLANT THIS YEAR. PATIENT FOLLOWED ALL MOBILITY INSTRUCTIONS AND RESTRICTIONS THAT WERE PROVIDED TO BY THE SURGEON POST OP. REDDISH INFLAMMATION AROUND THE AREA WHERE PROTRUDED IMPLANT IS NOTICEABLE. THE TOE IS BENT SIDEWAYS TOWARDS THE BIG TOE, 2ND TWO FROM THE BIG TOE".

  Patient problems: Deformity/ Disfigurement; Discomfort; Failure of Implant; Implant Pain; Inflammation; Unspecified Infection

  MAUDE report 16678073 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY SURGERY TOOK PLACE IN (B)(6). THE PATIENT REPORTED UNCHANGED PRE-EXISTING LOAD-DEPENDENT PAIN IN THE LEFT FOREFOOT, WITH THE TOES LL - LV EQUALLY PAINFUL. LEFT FOOT: INTEGUMENT INTACT WITH SCARRING WITHOUT IRRITATION. PAIN PROVOCATION WHEN MANIPULATING THE PRP JOINT DIG. LL - LV. DLP JOINT _DEG DIG. IV IN A SUBLUXATED PLANTAR POSITION. BEGINNING MALLET TOE SHAPE ALSO LL AND LLL, BUT CAN BE REPOSITIONED. SQUEEZE-IEST NEGATIVE. NO MULDER'S CLICK. MODERATE PLANTAR HYPERTENSION MTP V-JOINT. PO-NAS INTACT. X-RAY FOOT TO THE SIDE / OBLIQUE LEFT FROM (B)(6) 2020: NEW LYSIS BORDER AROUND THE DISTAL IMPLANT COMPONENT IN THE MIDDLE PHALANX IV AND FRACTURE OF THE PROXIMAL IMPLANT COMPONENT IN THE PROXIMAL PHALANX IV. THE SMART TOE IMPLANTS IN THE 2ND AND 3RD BEAM INTACT AND WITHOUT SIGNS OF EASING WITH ALSO ADVANCED CONSOLIDATION. WELL KNOWN ST.N. HAMME TOE CORRECTION DIG. LL-LV USING SMART TOE LMPLANTATEN WITH NEW FRACTURE AND LOOSENING OF THE IMPLANT IN DIG. LV AND LACK OF CONSOLIDATION THERE. NO PROGRESSIVE DEGENERATION. NOT A MORTON'S NEUROMA. A NEW CLINICAL AND RADIOLOGICAL RUPTURE OF THE SMART TOE IMPLANT OF THE DIG IS EVIDENT. IV. IN ADDITION, THERE WAS A SLIGHT L

  Patient problems: Implant Pain

  MAUDE report 10771548 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY SURGERY TOOK PLACE IN (B)(6) BERN ON (B)(6) 2017. THE PATIENT REPORTED UNCHANGED PRE-EXISTING LOAD-DEPENDENT PAIN IN THE LEFT FOREFOOT, WITH THE TOES LL - LV EQUALLY PAINFUL. LEFT FOOT: INTEGUMENT INTACT WITH SCARRING WITHOUT IRRITATION. PAIN PROVOCATION WHEN MANIPULATING THE PRP JOINT DIG. LL - LV. DLP JOINT _DEG DIG. IV IN A SUBLUXATED PLANTAR POSITION. BEGINNING MALLET TOE SHAPE ALSO LL AND LLL, BUT CAN BE REPOSITIONED. SQUEEZE-IEST NEGATIVE. NO MULDER'S CLICK. MODERATE PLANTAR HYPERTENSION MTP V-JOINT. PO-NAS INTACT. X-RAY FOOT TO THE SIDE / OBLIQUE LEFT FROM ON (B)(6) 2020: NEW LYSIS BORDER AROUND THE DISTAL IMPLANT COMPONENT IN THE MIDDLE PHALANX IV AND FRACTURE OF THE PROXIMAL IMPLANT COMPONENT IN THE PROXIMAL PHALANX IV. THE SMART TOE IMPLANTS IN THE 2ND AND 3RD BEAM INTACT AND WITHOUT SIGNS OF EASING WITH ALSO ADVANCED CONSOLIDATION. WELL KNOWN ST.N. HAMME TOE CORRECTION DIG. LL-LV USING SMART TOE IMPLANTATION WITH NEW FRACTURE AND LOOSENING OF THE IMPLANT IN DIG. LV AND LACK OF CONSOLIDATION THERE. NO PROGRESSIVE DEGENERATION. NOT A MORTON'S NEUROMA. A NEW CLINICAL AND RADIOLOGICAL RUPTURE OF THE SMART TOE IMPLANT OF THE DIG IS EVIDENT. IV. IN ADDITI

  Patient problems: Implant Pain

  MAUDE report 10771309 ↗
• MalfunctionJun 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE REP WAS NOTIFIED THAT A LEG OF THE PATIENT'S SMART TOE IMPLANT WAS BROKEN. POSSIBLE CAUSE OR CONTRIBUTOR FOR THE BREAKAGE WAS NOT REPORTED TO THE REP. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10116914 ↗