Affixus® Natural Nail® 47-2496-240-07Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Affixus Natural Nail (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024505957), received between Oct 4, 2021 and Jul 26, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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 18, 2026.
Most reported problems
Device problems
- Migration1
- Migration or Expulsion of Device1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2023Migration; Migration
IT WAS REPORTED THAT THE SCREWS HAVE STARTED TO BACK OUT OF THE NAIL APPROXIMATELY TWO (2) MONTHS POST IMPLANTATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DUE DILIGENCE IS COMPLETED FOR THIS COMPLAINT; TO DATE WHATEVER ADDITIONAL INFORMATION RECEIVED HAS BEEN CAPTURED IN THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17395410 ↗MalfunctionOct 4, 2021Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 12568535 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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