VOLT Wrist Treatment SystemRecalls & reported problems across all models
Tyber Medical, LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one VOLT Wrist Treatment System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of VOLT Wrist Treatment System by Tyber Medical, LLC in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jun 12, 2026 and Jun 12, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
VOLT Wrist Treatment System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 19, 2025Open, Classified
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Z-1132-2026 · Root cause: Process control · Recall details · FDA record ↗
- Dec 19, 2025Open, Classified
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Z-1131-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported VOLT Wrist Treatment System problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
VOLT Wrist Treatment System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VOLT™ Wrist Treatment System 02.426.681SPlate, fixation, bone1 recall0 reports
- VOLT™ Wrist Treatment System 02.426.691SPlate, fixation, bone1 recall0 reports
- Volt™ Wrist Treatment System 02.426.530Plate, fixation, bone1 report
Recent VOLT Wrist Treatment System adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Device-Device Incompatibility
FIRST TIME SYSTEM USER. MULTIPLE SCREWS WOULD NOT LOCK INTO THE PLATE. MOST ULNAR, 2ND MOST ULNAR, AND RADIAL STYLOID SCREW. WE TRIED EVERY SINGLE LOCKING GUIDE, CHANGING THE TRAJECTORY OF OUR DRILL, SWAPPING TO A NEW PLATE, BURNED 12 SCREWS. WE LEARNED THINGS ABOUT THE PLATE INCLUDING THAT THE LOCKING THREADS OF THE SCREW ITSELF GO PAST THE PLATE. SO WHEN THE PLATE IS NOT SITTING FLUSH THEY CAN LOCK IN, WHEN IT IS THEY CANNOT. ALSO THE PLATE HAS LITTLE TO NO TOLERANCE FOR ACTUAL VA DRILLING. YOU HAVE TO BE PERFECTLY ALIGNED WITH THE HOLE IN ORDER TO GET IT TO LOCK.TRYING EVERYTHING WE COULD DO MAKE IT WORK. INCLUDING SWAPPING PLATES, SCREWS, DRILL GUIDES, DRILL TRAJECTORY. 45 MINUTES SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. SUBOPTIMAL FIXATION ON AN 82YO. NO OTHER MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485849 ↗
Other Tyber Medical, LLC products
All Tyber Medical, LLC 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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