VariAx 57-15340SRecalls & reported problems
Stryker GmbH · 2.3 M VARIAX HAND LOCK T-PLATE, NARROW · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540542274), received between Aug 7, 2018 and Jan 26, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Retraction Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Fracture
AS REPORTED: "PATIENT NOTED INCREASED PAIN AND SWELLING, ATTENDED FOR ASSESSMENT ON IMAGING PLATE WAS FRACTURED. PLATE INSERTED DURING SURGERY HAS BROKEN WHILE IN SITU 5 WEEKS POST SURGERY. METALWORK HAS BEEN REVISED."
Patient problems: Pain; Swelling/ Edema
MAUDE report 24177517 ↗InjurySep 25, 2018Break
THE PLATE WAS BROKEN DUE TO PLACE HER HAND AFTER 8 WEEK LATER FROM INITIAL SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7907948 ↗MalfunctionAug 7, 2018Retraction Problem
AN UNKNOWN DAY, IMPLANTED THE VARIAX HAND. SINCE BONE FUSION WAS OBTAINED, SO ATTEMPTED TO REMOVE THE VARIAX HAND. ONLY ONE LOCKING SCREWS COULD NOT BE REMOVED, AND THE PLATE WAS PULLED OUT WITH THE LOCKING SCREW. THE PHYSICIAN REQUESTED US WHY THE LOCKING SCREW COULD NOT BE PULLED OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7756992 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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