Stryker Performance SeriesRecalls & reported problems across all models
Stryker Corporation · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 184
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 26 models of Stryker Performance Series by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 184 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2018 and Apr 22, 2026 — classified as 6 injuries, 178 malfunctions.
The most frequently reported specific device problem is “Fracture” (124 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 Performance Series problems
Device problems
- Fracture124
- Break29
- Delivered as Unsterile Product21
- Tear, Rip or Hole in Device Packaging8
- No Apparent Adverse Event4
- Packaging Problem4
- Difficult to Open or Remove Packaging Material1
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- No Consequences Or Impact To Patient31
- No Patient Involvement13
- Insufficient Information8
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient3
- No Known Impact Or Consequence To Patient1
Stryker Performance Series models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stryker Performance Series 6118127090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL37 reports
- Stryker Performance Series 6125127090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL28 reports
- Stryker Performance Series 6118127100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL22 reports
- Stryker Performance Series 6125119090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL16 reports
- Stryker Performance Series 6125127100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL12 reports
- Stryker Performance Series 6113127090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL9 reports
- Stryker Performance Series 6113119090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL8 reports
- Stryker Performance Series 6118127110BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL7 reports
- Stryker Performance Series 6118097090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL6 reports
- Stryker Performance Series 6118119100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL6 reports
- Stryker Performance Series 6118137090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Stryker Performance Series 6118119090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL4 reports
- Stryker Performance Series 6125089090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL4 reports
- Stryker Performance Series 6125097090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL3 reports
- Stryker Performance Series 6125137090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL3 reports
- Stryker Performance Series 6207097101BLADE, SAW, SURGICAL, CARDIOVASCULAR3 reports
- Stryker Performance Series 6118119110BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL2 reports
- Stryker Performance Series 6113089090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6118089090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6113127075BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6113127100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6118137100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6125100110BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6221127090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6221137090BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stryker Performance Series 6213147070INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
Recent Stryker Performance Series adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 2 EVENTS HAD IMAGING REQUIRED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24954376 ↗MalfunctionApr 22, 2026Delivered as Unsterile Product
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31, 2026. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: DELIVERED AS UNSTERILE PRODUCT. 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD INSUFFICIENT INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24954310 ↗MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) ¿ (B)(6) 2026. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954010 ↗MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953977 ↗MalfunctionApr 17, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911747 ↗MalfunctionJan 23, 2026Fracture
MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD IMAGING REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163975 ↗MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163724 ↗MalfunctionJan 23, 2026Delivered as Unsterile Product
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: DELIVERED AS UNSTERILE PRODUCT. - 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163581 ↗MalfunctionJan 23, 2026Fracture
MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163407 ↗InjuryNov 25, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A ROUTINE POST-OPERATIVE CHECK-UP USING AN X-RAY, A FOREIGN BODY WAS DETECTED IN THE SURGICAL FIELD. THE PATIENT WAS REOPENED, AND THE BLADE FRAGMENT REMOVED. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645819 ↗MalfunctionNov 7, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23496717 ↗MalfunctionOct 28, 2025Fracture; Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399961 ↗MalfunctionOct 28, 2025Fracture; Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD IMAGING REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399919 ↗
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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