SMART TOE ST0-15PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252263302), received between Aug 24, 2022 and Jan 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Difficult to Remove; Difficult to Remove

  ANSM REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2021 FOR ARTHRODESIS OF THE 4TH LEFT TOE, USING A SMART TOE CENTROMEDULLARY IMPLANT. SIZE 15. SUBSEQUENTLY, THE ARTHRODESIS DID NOT CONSOLIDATE. THE IMPLANT FAILED. IT WAS THEREFORE NECESSARY TO CONSIDER TO PERFORM A NEW ARTHRODESIS, REMOVE THE IMPLANT AND USE A NEW TOE GRIP CENTROMEDULLARY IMPLANT." (EVENT COVERED UNDER ANOTHER COMPLAINT MFR REPORT#: 0008031020-2023-00439). "THE SURGEON OPERATED ON THE PATIENT ON (B)(6) 2023. IT WAS TOTALLY IMPOSSIBLE TO REMOVE THE SMART TOE, EVEN BY RELEASING THE PROXIMAL CLOSE. THE 2 PHALANGES WOULD HAVE HAD TO BE "SPLIT OPEN". PATIENT'S CURRENT CONDITION: ARTHRODESIS HAD TO BE PERFORMED WITH ANOTHER DEVICE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: THE SURGEON LEFT THE SMART TOE IMPLANT IN PLACE AND PERFORMED ARTHRODESIS USING 2 CROSSED PINS, ONE PIN POSITIONED ABOVE THE IMPLANT, ONE PIN POSITIONED BELOW THE IMPLANT. THE PINS WERE INSERTED UNDER SCOPIC CONTROL, AND THE PATIENT HAD TO KEEP THEM IN PLACE FOR 6 WEEKS."

  Patient problems: Failure of Implant

  MAUDE report 18474489 ↗
• InjuryDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ANSM REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2021 FOR ARTHRODESIS OF THE 4TH LEFT TOE, USING A SMART TOE CENTROMEDULLARY IMPLANT. SIZE 15. SUBSEQUENTLY, THE ARTHRODESIS DID NOT CONSOLIDATE. THE IMPLANT FAILED. IT WAS THEREFORE NECESSARY TO CONSIDER TO PERFORM A NEW ARTHRODESIS, REMOVE THE IMPLANT AND USE A NEW TOE GRIP CENTROMEDULLARY IMPLANT." "THE SURGEON OPERATED ON THE PATIENT ON (B)(6) 2023. IT WAS TOTALLY IMPOSSIBLE TO REMOVE THE SMART TOE, EVEN BY RELEASING THE PROXIMAL CLOSE. THE 2 PHALANGES WOULD HAVE HAD TO BE "SPLIT OPEN". PATIENT'S CURRENT CONDITION: ARTHRODESIS HAD TO BE PERFORMED WITH ANOTHER DEVICE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: THE SURGEON LEFT THE SMART TOE IMPLANT IN PLACE AND PERFORMED ARTHRODESIS USING 2 CROSSED PINS, ONE PIN POSITIONED ABOVE THE IMPLANT, ONE PIN POSITIONED BELOW THE IMPLANT. THE PINS WERE INSERTED UNDER SCOPIC CONTROL, AND THE PATIENT HAD TO KEEP THEM IN PLACE FOR 6 WEEKS." (EVENT COVERED UNDER ANOTHER COMPLAINT STRYKER REF (B)(4)).

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

  MAUDE report 18370821 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 IT WAS REPORTED THAT AT 6 WEEK POST OP X-RAYS IT WAS FOUND THAT A PATIENT HAD SUFFERED A COMPLICATION AND WILL REQUIRE A REVISION.

  Patient problems: Insufficient Information

  MAUDE report 15287649 ↗