Affixus® Natural Nail® 47-2486-124-40Recalls & 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 00889024505322), received between Aug 20, 2026 and Aug 20, 2026 — classified as 2 injuries.
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 Problem2
Patient problems
- Bursitis2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
The clinical study reported that the patient underwent an Initial left humerus open reduction and internal fixation. Subsequently the patient received a steroid injection for subacromial bursitis. Due diligence is in progress for this complaint; to date no additional information or product has been received.
Patient problems: Bursitis
MAUDE report 50340469 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
The clinical study reported that the patient underwent an Initial left humerus open reduction and internal fixation. Subsequently the patient received a steroid injection for subacromial bursitis. Due diligence is in progress for this complaint; to date no additional information or product has been received.
Patient problems: Bursitis
MAUDE report 50340394 ↗
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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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