restor3d Kinos Axiom PSR 5831-9006Recalls & reported problems
Restor3d, Inc. · Axiom coupled PSR, Flat-cut · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840097509945), received between Jul 16, 2026 and Jul 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Wrong Label” (1 report).
1 FDA recall record name this device's identifier, 1 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, 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 18, 2026.
Reports received per month
Recalls naming this device
- Jul 27, 2026Class IIOpen, Classified
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
Z-3178-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Wrong Label1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Wrong Label
THE SURGEON RECEIVED THE CORRECT ANATOMIC MODEL FOR CASE 18059, BUT THE CUTTING GUIDES THAT WERE INSIDE THE PACKAGE BELONGED TO A DIFFERENT CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841686 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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