VARIAXRecalls & reported problems across all models
Stryker GmbH · 345 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 891
- Deaths reported
- 0
- Injuries reported
- 292
- Recalls
- 0
We found 345 models of VARIAX by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 891 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2015 and Sep 17, 2026 — classified as 292 injuries, 599 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (224 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 VARIAX problems
Device problems
- Positioning Failure224
- Fracture175
- Break160
- Material Fragmentation108
- Adverse Event Without Identified Device or Use Problem78
- Migration34
- Device Dislodged or Dislocated33
- Detachment of Device or Device Component25
Patient problems
- No Clinical Signs, Symptoms or Conditions341
- No Known Impact Or Consequence To Patient199
- Failure of Implant90
- Injury57
- Reaction53
- Insufficient Information52
- Foreign Body In Patient49
- Nonunion/Delayed-union Bone Fracture38
VARIAX models
345 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- VARIAX 657314SPLATE, FIXATION, BONE31 reports
- VARIAX 657316SPLATE, FIXATION, BONE29 reports
- VARIAX 657312Screw, fixation, bone21 reports
- VARIAX 657312SPLATE, FIXATION, BONE18 reports
- VARIAX 657314Screw, fixation, bone18 reports
- VARIAX 705297CLAMP17 reports
- VARIAX 657316Screw, fixation, bone16 reports
- VariAx 656320Screw, fixation, bone15 reports
- VariAx 656318Screw, fixation, bone14 reports
- VariAx 656316Screw, fixation, bone12 reports
- VariAx 656318SScrew, fixation, bone12 reports
- VARIAX 657320SPLATE, FIXATION, BONE12 reports
- VariAx 656418Screw, fixation, bone11 reports
- VARIAX 45-27015ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- VARIAX 657310SPLATE, FIXATION, BONE10 reports
- VARIAX 657318SPLATE, FIXATION, BONE10 reports
- VARIAX 657322Screw, fixation, bone10 reports
- VARIAX 703822ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- VariAx 656314Screw, fixation, bone9 reports
- VariAx 656416Screw, fixation, bone9 reports
- VARIAX 703896Orthopedic Manual Surgical Instrument8 reports
- VariAx 656316SScrew, fixation, bone8 reports
- VariAx 656320SScrew, fixation, bone8 reports
- VariAx 656312Screw, fixation, bone7 reports
- VARIAX 703690Orthopedic Manual Surgical Instrument7 reports
- VariAx 656314SScrew, fixation, bone7 reports
- VariAx 656414SScrew, fixation, bone7 reports
- VARIAX 657414Screw, fixation, bone7 reports
- VARIAX 657310Screw, fixation, bone7 reports
- VARIAX 657322SPLATE, FIXATION, BONE7 reports
- VARIAX 657324SPLATE, FIXATION, BONE7 reports
- VariAx 656020Screw, fixation, bone6 reports
- VariAx 656414Screw, fixation, bone6 reports
- VARIAX 657320Screw, fixation, bone6 reports
- VARIAX 657324Screw, fixation, bone6 reports
- VariAx 53-27214SPLATE, FIXATION, BONE5 reports
- VariAx 56-01210Orthopedic Manual Surgical Instrument5 reports
- VARIAX 703701Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment5 reports
- VariAx 656420Screw, fixation, bone5 reports
- VariAx 657016Screw, fixation, bone5 reports
- VARIAX 703880Orthopedic Manual Surgical Instrument5 reports
- VARIAX 629589PLATE, FIXATION, BONE5 reports
- VariAx 40-35614SPLATE, FIXATION, BONE4 reports
- VariAx 40-20904APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- VARIAX 628008SPLATE, FIXATION, BONE4 reports
- VARIAX 628030SPLATE, FIXATION, BONE4 reports
- VARIAX 628227SPLATE, FIXATION, BONE4 reports
- VariAx 54-25384PLATE, FIXATION, BONE4 reports
- VariAx 40-15011PLATE, FIXATION, BONE4 reports
- VariAx 656322Screw, fixation, bone4 reports
- VARIAX 703690SOrthopedic Manual Surgical Instrument4 reports
- VARIAX 657412SPLATE, FIXATION, BONE4 reports
- VARIAX 657450SPLATE, FIXATION, BONE4 reports
- VARIAX 657326Screw, fixation, bone4 reports
- VARIAX 657328Screw, fixation, bone4 reports
- VARIAX 657330SPLATE, FIXATION, BONE4 reports
- VARIAX 705134INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT4 reports
- VariAx 57-15340SPLATE, FIXATION, BONE3 reports
- VariAx 53-27212SPLATE, FIXATION, BONE3 reports
- VariAx 53-27216SPLATE, FIXATION, BONE3 reports
- VariAx 53-27622SPLATE, FIXATION, BONE3 reports
- VARIAX 62-27015Orthopedic Manual Surgical Instrument3 reports
- VARIAX 703713Plate, fixation, bone3 reports
- VariAx 40-15091PLATE, FIXATION, BONE3 reports
- VariAx 53-27216EPLATE, FIXATION, BONE3 reports
- VARIAX 614616PLATE, FIXATION, BONE3 reports
- VARIAX 614620PLATE, FIXATION, BONE3 reports
- VariAx 656324Screw, fixation, bone3 reports
- VariAx 656424Screw, fixation, bone3 reports
- VariAx 657116Screw, fixation, bone3 reports
- VariAx 656312SScrew, fixation, bone3 reports
- VARIAX 703896SOrthopedic Manual Surgical Instrument3 reports
- VARIAX 657416Screw, fixation, bone3 reports
- VARIAX 657420Screw, fixation, bone3 reports
- VARIAX 657432Screw, fixation, bone3 reports
- VARIAX 628526SPLATE, FIXATION, BONE3 reports
- VARIAX 657328SPLATE, FIXATION, BONE3 reports
- VARIAX 629579PLATE, FIXATION, BONE3 reports
- VARIAX 705133INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- VARIAX 45-35015ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- VARIAX 45-85000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- VARIAX 62-17333ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- VariAx 53-27614SPLATE, FIXATION, BONE2 reports
- VariAx 53-27616SPLATE, FIXATION, BONE2 reports
- VariAx 53-27624SPLATE, FIXATION, BONE2 reports
- VariAx 45-27010BIT, DRILL2 reports
- VARIAX 40-20806SPLATE, FIXATION, BONE2 reports
- VARIAX 40-20807SPLATE, FIXATION, BONE2 reports
- VARIAX 628007SPLATE, FIXATION, BONE2 reports
- VARIAX 628028SPLATE, FIXATION, BONE2 reports
- VariAx 54-25677SPLATE, FIXATION, BONE2 reports
- VariAx 54-25374PLATE, FIXATION, BONE2 reports
- VariAx 54-25385PLATE, FIXATION, BONE2 reports
- VariAx 54-25391PLATE, FIXATION, BONE2 reports
- VariAx 57-10310PLATE, FIXATION, BONE2 reports
- VariAx 57-15392PLATE, FIXATION, BONE2 reports
- VariAx 40-35616PLATE, FIXATION, BONE2 reports
- VariAx 45-80100Guide, Surgical, Instrument2 reports
- VariAx 52-27014SPLATE, FIXATION, BONE2 reports
- VariAx 53-27214EPLATE, FIXATION, BONE2 reports
Recent VARIAX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Insufficient Information
MAUDE report 50809703 ↗InjurySep 17, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Insufficient Information
MAUDE report 50809697 ↗InjuryAug 3, 2026Fracture
As reported "The Variax 2 plate was implanted on (b)(6) 2025 and fractured outside a medical facility. Subsequent removal and reosteosynthesis took place on (b)(6) 2026."Additionally, upon product return it was identified that one of the screws was also broken.
Patient problems: Insufficient Information
MAUDE report 50117582 ↗InjuryApr 15, 2026Fracture
AS REPORTED "THE VARIAX 2 PLATE WAS IMPLANTED ON (B)(6) 2025 AND FRACTURED OUTSIDE A MEDICAL FACILITY. SUBSEQUENT REMOVAL AND REOSTEOSYNTHESIS TOOK PLACE ON (B)(6) 2026."
Patient problems: Insufficient Information
MAUDE report 24887035 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED: "BONE RESORPTION FROM THE NONUNION WAS CONFIRMED".
Patient problems: Nonunion/Delayed-union Bone Fracture; Osteolysis
MAUDE report 24734304 ↗MalfunctionMar 30, 2026Material Fragmentation
AS REPORTED: "THE NON-LOCKING SCREW WAS INSERTED INTO THE FRACTURE SITE FOLLOWING DIRECT DRILLING. HOWEVER, UPON TURNING THE DRIVER, A THIN WIRE-LIKE OBJECT EMERGED FROM THE SCREW INSERTION SITE, NECESSITATING ITS REMOVAL. AS FIXATION OF THE FRACTURE BY THE SCREW WAS CONFIRMED, THE SCREW WAS NOT REMOVED AND WAS IMPLANTED IN THE PATIENT'S BODY. SUBSEQUENTLY, PLATE FIXATION WAS PERFORMED USING THE STANDARD TECHNIQUE. THE THIN WIRE-LIKE OBJECT WAS DISCARDED AT THE FACILITY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734297 ↗InjuryMar 30, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth
THE SURGEON GAVE PERMISSION TO MOVE, BUT CARRYING HEAVY OBJECTS WAS PROHIBITED. THE BONE HAD NOT HEALED, AND THE PATIENT DID NOT FOLLOW THE POSTOPERATIVE INSTRUCTIONS GIVEN BY THE PHYSICIAN AND CARRIED HEAVY OBJECTS. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, AND IT WAS FOUND THAT THE DISTAL SCREW HAD DISENGAGED. NON-UNION WAS NOTICED. THE FOLLOWING SCREWS WERE REPORTED: (b)(6). IT WAS REPORTED THAT THEY WERE UNABLE TO DETERMINE WHICH SCREW WAS LOOSE. HOWEVER, IT WAS REPORTEDLY THE DISTAL SCREW, ALTHOUGH IT IS UNKNOWN WHICH SPECIFIC SCREW. AS A RESULT, A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE PLATE AND THE SCREWS.
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 24710461 ↗MalfunctionMar 25, 2026Positioning Failure
AS REPORTED: "PLATE AND LOCKING SCREW LOCKING FAILURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691599 ↗MalfunctionMar 25, 2026Fracture; Difficult to Remove
THE CUSTOMER REPORTED THE FOLLOWING: "DURING WRIST OSTEOSYNTHESIS USING A PLATE, THE HEAD OF A CORTICAL SCREW BROKE. THIS INCIDENT MADE IT DIFFICULT TO REMOVE THE SCREW AND THEREFORE HAD AN IMPACT ON THE DURATION OF THE PROCEDURE. HOWEVER, IT WAS EVENTUALLY REMOVED. THE SCREW CAME FROM THE VARIAX WRIST ANCILLARY. AFTER SOME TIME, THE SURGEON SUCCESSFULLY REMOVED THE DEFECTIVE MATERIAL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688558 ↗InjuryMar 19, 2026Fracture
IT WAS REPORTED VIA MEDWATCH #MW5182803: "DRILL BIT USED IN A JOINT OF THE FOOT. AFTER USE AND EXAMINATION, IT WAS NOTED THAT THE TIP OF THE DRILL WAS BROKEN. DRILL BIT WAS LEFT IN BONE AS ATTEMPTING TO REMOVE IT COULD CAUSE MORE DAMAGE". NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24640819 ↗MalfunctionMar 10, 2026Fracture
AS REPORTED: "ONE TIP OF THE REDUCTION FORCEPS HAS BROKEN OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559244 ↗MalfunctionMar 3, 2026Fracture
DURING TREATMENT FOR A DISTAL RADIUS FRACTURE, A 2.7 MM CORTICAL SCREW WAS INSERTED TO DRAW THE PLATE AND BONE SURFACE TOGETHER, BUT THE SCREW HEAD SHEARED OFF. (THE SCREW HEAD REMAINS STUCK IN THE DRIVER TIP.).
Patient problems: Insufficient Information
MAUDE report 24498480 ↗InjuryFeb 26, 2026Fracture
AS REPORTED: "ON (b)(6) 2024, THE PATIENT UNDERWENT SURGERY ON HIS LEFT WRIST. IT WAS FUSED USING THE VARIAX 2 WRIST FUSION. IN (b)(6) 2025, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. THE MATERIAL WAS THEN REMOVED ON (b)(6) 2025. THE PATIENT REPORTED PAIN IN THE WRIST AND A LACK OF STRENGTH IN HIS DOMINANT HAND."
Patient problems: Muscle Weakness/Atrophy; Pain
MAUDE report 24457741 ↗MalfunctionFeb 24, 2026Positioning Failure
THE CUSTOMER REPORTED THAT "DURING OSTEOSYNTHESIS OF THE LEFT DISTAL RADIUS USING A VARIAX PLATE AND SCREWS ON A DISPLACED FRACTURE, THE SURGEON ENCOUNTERED DIFFICULTIES WHEN INSERTING A 2.7 MM DIAMETER, 16 MM LONG LOCKING SCREW. THE FIRST FOUR SCREWS WERE INSERTED WITHOUT ANY PROBLEMS, BUT ¿THE FIFTH SCREW DID NOT LOCK INTO THE PLATE'S THREAD AND SPUN FREELY.¿ FURTHERMORE, DESPITE MULTIPLE ATTEMPTS, IT WAS IMPOSSIBLE TO REMOVE. THE SURGEON DECIDED TO REMOVE THE PLATE AND SCREWS AND USE A NEW PLATE AND NEW SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431118 ↗MalfunctionFeb 24, 2026Device Difficult to Setup or Prepare
THE CUSTOMER REPORTED THAT "DURING OSTEOSYNTHESIS OF THE LEFT DISTAL RADIUS USING A VARIAX PLATE AND SCREWS ON A DISPLACED FRACTURE, THE SURGEON ENCOUNTERED DIFFICULTIES WHEN INSERTING A 2.7 MM DIAMETER, 16 MM LONG LOCKING SCREW. THE FIRST FOUR SCREWS WERE INSERTED WITHOUT ANY PROBLEMS, BUT ¿THE FIFTH SCREW DID NOT LOCK INTO THE PLATE'S THREAD AND SPUN FREELY.¿ FURTHERMORE, DESPITE MULTIPLE ATTEMPTS, IT WAS IMPOSSIBLE TO REMOVE. THE SURGEON DECIDED TO REMOVE THE PLATE AND SCREWS AND USE A NEW PLATE AND NEW SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431117 ↗
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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