Affixus® Natural Nail® 47-2496-261-08Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024506053), received between Jun 10, 2021 and Jun 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical 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.
Most reported problems
Device problems
- Mechanical Problem1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2021Mechanical Problem; Migration; Mechanical Problem; Migration
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND THREE WEEKS POST IMPLANTATION THE PROXIMAL SCREW BACKED OUT CAUSING DAMAGES TO THE ARM SOFT TISSUES. REVISION SURGERY IS NOT PLANNED YET.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 11973775 ↗
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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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