Affixus® Natural Nail® 47-2497-280-09Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024506220), received between Apr 21, 2025 and Apr 21, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Separation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Separation Problem1
Patient problems
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
- Osteopenia/ Osteoporosis1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT THE PATIENT AFTER A MONTH POST IMPLANTATION WENT FOR A REVISION SURGERY FOR THE REMOVAL OF A SCREW DUE TO MIGRATION BECAUSE OF OSTEOPOROSIS THE SUBJECT IS REPORTED AS IMPROVED/RECUPERATED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 21875723 ↗InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 21875708 ↗
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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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