Stryker PrecisionRecalls & reported problems across all models
Stryker Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Stryker Precision by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Jul 22, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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 Precision problems
Device problems
- Fracture8
- Detachment of Device or Device Component5
- Break3
- Delivered as Unsterile Product2
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient4
- No Patient Involvement4
- No Consequences Or Impact To Patient3
Stryker Precision models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stryker Precision 6425127105INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT13 reports
- Stryker Precision 6209000000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT7 reports
Recent Stryker Precision adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907824 ↗MalfunctionJan 21, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200775 ↗MalfunctionJan 22, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556976 ↗MalfunctionJul 26, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17397003 ↗MalfunctionMar 15, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN METAL FRAGMENT WAS REMOVED WITH A HEMOSTAT AND THERE WERE NO FRAGMENTS LEFT BEHIND IN THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13773414 ↗MalfunctionNov 15, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING PREPARATION FOR A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12813860 ↗MalfunctionNov 9, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING PREPARATION FOR A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780292 ↗MalfunctionNov 1, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12728079 ↗MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL PROCEDURE, A RESIDUE WAS NOTED ON THE BLADE . IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12042257 ↗MalfunctionJul 13, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SEAL ON THE PACKAGING OF THE DEVICE WAS OPEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10265236 ↗MalfunctionMar 23, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT, DURING A TKA (TOTAL KNEE ARTHROPLASTY) , WHEN A NURSE WAS OPENING THE PACKAGE, SHE NOTICED A PINHOLE ON IT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9866827 ↗MalfunctionJul 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8816611 ↗MalfunctionApr 18, 2019Break; Break
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPDATE; IT WAS SUBSEQUENTLY REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8529500 ↗MalfunctionJan 29, 2019Break; Break
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING A TKA (TOTAL KNEE ARTHROPLASTY) PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8286858 ↗MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 8285061 ↗
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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