Affixus® Natural Nail® 47-2496-280-08Recalls & 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 00889024506084), received between Jun 9, 2023 and Jun 9, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Migration1
- Separation Problem1
Patient problems
- Failure of Implant2
- Pain2
- Aseptic loosening1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2025Separation Problem; Separation Problem
IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN ORIF OF THE RIGHT PROXIMAL HUMERUS. SUBSEQUENTLY, THE PATIENT UNDERWENT REMOVAL OF A PROXIMAL SCREW 4 MONTHS POST IMPLANTATION DUE TO PAIN AND LOOSENING. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Aseptic loosening; Failure of Implant; Pain
MAUDE report 22167631 ↗InjuryJun 9, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17097498 ↗
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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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