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VariAx 54-25384Recalls & reported problems

Stryker GmbH · VOLAR SMARTLOCK DR PLATE,NARR. RI,SHORT · Class 2 · Implant

All models of VARIAX (345)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154345502), received between Jun 14, 2018 and Oct 13, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fracture2
  • Loose or Intermittent Connection1
  • Positioning Failure1

Patient problems

  • Failure of Implant2
  • Injury2
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Consequences Or Impact To Patient1
  • Pain1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 13, 2020Positioning Failure; Positioning Failure

    PHARMACIST REPORTED TO STRYKER THAT: "DURING A PROCEDURE, IT WAS IMPOSSIBLE TO INSERT ONE OF THE LOCKED SCREWS INTO ONE OF THE HOLES IN THE PLATE, WHICH PREVENTED THE PLATE FROM BEING FIXED. THE EXISTING SCREWS AND THE PLATE WERE REMOVED IN ORDER TO INSTALL A NEW PLATE. CLINICAL CONSEQUENCES : NOTHING TO REPORT. ACTION TAKEN: DEVICE QUARANTINED, AWAITING RETRIEVAL AND EXPERTISE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10673048 ↗
  • InjuryFeb 5, 2020Fracture; Fracture

    THE CUSTOMER REPORTED THAT THE VARIAX DISTAL RADIUS PLATE BROKE AND REQUIRES FUTURE REVISION SURGERY.

    Patient problems: Failure of Implant; Injury

    MAUDE report 9672356 ↗
  • InjuryNov 6, 2019Fracture

    X-RAYS SHOWED PLATE FRACTURE, LEADING TO REVISION SURGERY.

    Patient problems: Failure of Implant; Injury; No Code Available; Pain

    MAUDE report 9288612 ↗
  • MalfunctionJun 14, 2018Loose or Intermittent Connection

    AS REPORTED IN ETHICS HOTLINE CASE NUMBER (B)(4): "ON (B)(6) 2018, AT LEAST ONE SCREW AND ONE PLATE MALFUNCTIONED WHILE A SURGEON WAS TRYING TO PUT IN A WALKING PEG. THE PROCEDURE WAS DONE CORRECTLY, BUT WHEN THE SCREW WAS USED IT ONLY SPUN AND COULD NOT ENGAGE. A SECOND SCREW, HOWEVER, DID ENGAGE SUCCESSFULLY". REP VERBALLY REPORTED A 10 MIN SURGICAL DELAY, NO ADVERSE CONSEQUENCES TO THE PATIENT. PRIMARY PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7600641 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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