FormulaRecalls & reported problems across all models
Stryker Corporation · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 350
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 0
We found 43 models of Formula by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 350 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and Sep 17, 2026 — classified as 31 injuries, 319 malfunctions.
The most frequently reported specific device problem is “Break” (150 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 Formula problems
Device problems
- Break150
- Material Fragmentation84
- Device Contaminated During Manufacture or Shipping31
- Contamination /Decontamination Problem20
- Overheating of Device16
- Smoking9
- Adverse Event Without Identified Device or Use Problem8
- Packaging Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions230
- No Known Impact Or Consequence To Patient92
- Insufficient Information67
- No Consequences Or Impact To Patient15
- Foreign Body In Patient13
- Burn(s)9
- Burn, Thermal5
- No Patient Involvement4
Formula models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Formula 0375544000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL98 reports
- Formula 0375562000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL23 reports
- Formula 0375941000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL22 reports
- Formula 0375704500BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL22 reports
- Formula 0375545000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL22 reports
- Formula 0380544100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL21 reports
- Formula 0375542000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL20 reports
- Formula 0375941012BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL17 reports
- Formula 0375628000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL9 reports
- Formula 0375708500BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL8 reports
- Formula 0375532000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL8 reports
- Formula 0375638000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL7 reports
- Formula 0375554000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL6 reports
- Formula 0375940012BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Formula 0375951100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Formula 0375534000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Formula 0375555000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Formula 0375564000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Formula 0375565000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL5 reports
- Formula 0375951012BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL4 reports
- Formula 0380545100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL4 reports
- Formula 0380544150BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL3 reports
- Formula 0375552000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL3 reports
- Formula 0375951000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL2 reports
- Formula 0375543000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL2 reports
- Formula 0375637000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL2 reports
- Formula 0375940000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375940200BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375951112BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0380542150BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0380545150BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0385544000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0385544100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0385545100BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0385545000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0385943000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0385950008BUR, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- Formula 0375701500BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375541000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375627000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375636000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375647000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Formula 0375832000BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
Recent Formula adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810268 ↗MalfunctionJun 23, 2026Break; Material Fragmentation
IT WAS REPORTED THAT DURING SHAVER OPERATION, THE TIP FRACTURED AND FELL INTO THE PATIENT¿S SHOULDER JOINT CAVITY. THE SURGEON RETRIEVED THE BROKEN FRAGMENTS AND REMOVED THEM PROMPTLY. NO MISSING PARTS OF THE CUTTER HEAD WERE FOUND AFTER INSPECTION, AND A NEW DEVICE WAS USED THEREAFTER. THIS INCIDENT PROLONGED THE OPERATIVE DURATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601879 ↗MalfunctionMay 6, 2026Material Fragmentation
IT WAS REPORTED THAT UPON ATTEMPTING TO UTILIZE THE INSTRUMENT, AND PRIOR TO INSTRUMENT ENTERING PATIENT, THE SURGEON NOTED THAT THE INSTRUMENT WAS NOT BEHAVING AS NORMAL, AND HANDED INSTRUMENT BACK TO SURGICAL TECH, WHOM DISCOVERED THAT A PORTION OF THE INTERNAL CUTTING MECHANISM HAD BROKEN OFF INSIDE THE OUTER PORTION OF THE INSTRUMENT (THE CUTTING PORTION OF THE BURR HAD BROKEN OFF INSIDE THE TROCAR). ALL PARTS REMAINED INSIDE THE INSTRUMENT, AND ALL PARTS ARE ACCOUNTED FOR. NO PORTION OF THE INSTRUMENT WENT INSIDE THE PATIENT DURING SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25105291 ↗InjuryMar 31, 2026Material Fragmentation
IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, A FRACTION OF A BURR TIP FRACTURED AND REMAINED INSIDE THE PATIENT. DURING THE PATIENT'S FIRST POSTOPERATIVE VISIT AN X-RAY CONFIRMED THE FRAGMENT REMAINED IN THE PATIENT AND A FOLLOWUP SURGERY WAS PERFORMED TO REMOVE THE FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 24746562 ↗MalfunctionMar 30, 2026Overheating of Device
IT WAS REPORTED THAT DURING USE, THE KNIFE LEFT BLACK MARKS ON SOFT TISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736442 ↗MalfunctionMar 25, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A MENISCECTOMY, THE INNER SHAFT OF THE SHAVER SEEMINGLY GOT CAUGHT ONTO SOMETHING AND SNAPPED RIGHT OFF INTO THE JOINT. THERE WAS A 5 MINUTE DELAY TO FISH OUT THE BROKEN PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24692123 ↗MalfunctionMar 25, 2026Smoking
IT WAS REPORTED THAT THERE WAS EXCESSIVE FRICTION AND SMOKE FROM THE MOMENT IT WAS SWITCHED ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691305 ↗MalfunctionMar 18, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE SHAVER BLADE HAD SMALL PIECES OF PLASTIC INSIDE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626356 ↗MalfunctionFeb 24, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT AFTER OPENING STERILE PACKAGE AND INSPECTING ITEM, SOME TYPE OF MATERIAL WAS OBSERVED IN THE JAWS OF THE CUTTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436987 ↗MalfunctionFeb 24, 2026Material Fragmentation
IT WAS REPORTED THAT IT WAS DISCOVERED THAT ONE TOOTH WAS MISSING FROM THE CTR. THERE WAS IMMEDIATELY FILM AND EXTENSIVE RINSING, AND FILTER TO SEARCH FOR NO RESIDUE. THE FILM INDICATED THERE WAS NO RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436985 ↗MalfunctionFeb 19, 2026Overheating of Device
IT WAS REPORTED THAT THE SHAVER BLADE STARTS TO BURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396101 ↗MalfunctionFeb 5, 2026Material Fragmentation
IT WAS REPORTED THERE WAS AN ISOLATED INCIDENT WITH NO SERIOUS CONSEQUENCES FOR THE PATIENT. THERE WAS BREAKAGE OF A RESECTOR BLADE REFERENCE 0375-562-000, BATCH NUMBER 25157CE2. THE PROBLEM WAS RESOLVED BY USING A DIFFERENT BLADE. THE SHAVER BROKE ON THE MORNING OF JANUARY 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274157 ↗MalfunctionFeb 5, 2026Material Fragmentation
IT WAS REPORTED THERE WAS AN ISOLATED INCIDENT WITH NO SERIOUS CONSEQUENCES FOR THE PATIENT. THERE WAS BREAKAGE OF A RESECTOR BLADE REFERENCE (B)(4), BATCH NUMBER 25157CE2. THE PROBLEM WAS RESOLVED BY USING A DIFFERENT BLADE. THE SHAVER BROKE ON THE MORNING OF (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274135 ↗MalfunctionFeb 3, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE FORMULA AGGRESSIVE PLUS CUTTER CAME APART IN THE PATIENT. THE SURGEON FISHED IT OUT WITH A GRASPER SO NOTHING WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24252876 ↗MalfunctionFeb 3, 2026Material Fragmentation
IT WAS REPORTED THAT A CHIPPED SHAVER TIP WAS DETECTED DURING SURGERY. THE SHAVER TIP WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE SURGERY ITSELF WAS COMPLETED WITHOUT ISSUE. THE SALES REP WAS CONTACTED AND CONFIRMED THAT ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24252864 ↗
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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