Stryker SmartLifeRecalls & reported problems across all models
Stryker Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 146
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Stryker SmartLife by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Jul 24, 2025 — classified as 146 malfunctions.
The most frequently reported specific device problem is “Fracture” (119 reports).
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
Most reported Stryker SmartLife problems
Device problems
- Fracture119
- Difficult to Open or Close19
- Detachment of Device or Device Component8
- Overheating of Device2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- No Consequences Or Impact To Patient52
- No Known Impact Or Consequence To Patient9
- No Patient Involvement8
- Insufficient Information6
Stryker SmartLife models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stryker SmartLife 7222120000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT143 reports
- Stryker SmartLife 7212000000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- Stryker SmartLife 7215000000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
Recent Stryker SmartLife adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Fracture; Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587108 ↗MalfunctionApr 21, 2025Difficult to Open or Close; Difficult to Open or Close
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876251 ↗MalfunctionJan 21, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 5 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201198 ↗MalfunctionNov 21, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20750668 ↗MalfunctionOct 24, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING INSPECTION. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20523538 ↗MalfunctionOct 21, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 7 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20498938 ↗MalfunctionSep 23, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD BEFORE A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20278205 ↗MalfunctionAug 27, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING SURGICAL DELAY OR MEDICAL INTERVENTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20073010 ↗MalfunctionJul 24, 2024Difficult to Open or Close; Difficult to Open or Close
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19823245 ↗MalfunctionJul 24, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822983 ↗MalfunctionJul 10, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFORMATION NEEDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19716067 ↗MalfunctionJan 22, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18557745 ↗MalfunctionJan 18, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18536336 ↗MalfunctionNov 16, 2023Fracture; Fracture
THE USER FACILITY REPORTED THAT THE HOUSING BROKE AT THE WELD FOUND AFTER A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18152666 ↗MalfunctionOct 23, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17992990 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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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