SMART TOERecalls & reported problems across all models
Stryker GmbH · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SMART TOE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 1
We found 8 models of SMART TOE by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2016 and Feb 9, 2026 — classified as 13 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SMART TOE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 5 of these models · Recall details · FDA record ↗
Most reported SMART TOE problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Fracture3
- Material Rupture2
- Premature Activation2
- Activation Failure1
- Break1
- Difficult to Remove1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant7
- Implant Pain4
- Insufficient Information3
- Deformity/ Disfigurement2
- No Known Impact Or Consequence To Patient2
- Ambulation or Postural Difficulties1
- Discomfort1
- Hypersensitivity/Allergic reaction1
SMART TOE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SMART TOE ST0A-16PPIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PPIN, FIXATION, SMOOTH1 recall2 reports
- SMART TOE ST0-22PPIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0XS-11PIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0XS-13PIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0A-19PPIN, FIXATION, SMOOTH4 reports
- SMART TOE ST0-15PPIN, FIXATION, SMOOTH3 reports
- SMART TOE ST0-16PPIN, FIXATION, SMOOTH2 reports
Recent SMART TOE adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 20284633 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionAug 26, 2021Activation Failure; Activation Failure
IT WAS REPORTED: "WHEN PLACING THE SMART TOE 2 IMPLANT DID NOT EXPAND UPON HEATING UP. NON EXPANDING IMPLANT WAS REMOVED AND EXCHANGED FOR DIFFERENT SMART TOE IMPLANT THAT PERFORMED AS EXPECTED. A SURGICAL DELAY OF 45MIN WAS REPORTED."
Patient problems: Failure of Implant
MAUDE report 12374426 ↗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 ↗InjuryNov 2, 2020Fracture; Fracture
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: Failure of Implant; Implant Pain
MAUDE report 10771191 ↗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 ↗MalfunctionMar 11, 2019Manufacturing, Packaging or Shipping Problem
CUSTOMER REPORTED THAT INCORRECT IMPLANTS WERE FOUND IN PACKAGING UPON OPENING THE PRODUCT. THIS IMPLANT WAS NOT FITTED AND A NEW IMPLANT WAS USED WITH NO ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8409347 ↗InjuryDec 19, 2016Material Rupture
IT WAS REPORTED BY THE RISK MANAGER, RELATED TO ANSM THAT " ARTHRODESIS ON 2ND TOE, RIGHT AND LEFT. THE PATIENT HAS BEEN EXAMINED 1 MONTH LATER : RUPTURE OF THE 2 IMPLANTS (X-RAY IMAGES). NO CONSEQUENCE BECAUSE THE ARTHRODESIS IS OK."
Patient problems: Failure of Implant
MAUDE report 6184986 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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