ZUK 00579104400Recalls & reported problems
Smith & Nephew, Inc. · 33mm Headed Screw · Class 1
All models of ZUK (46)
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 00885556618981), received between Sep 28, 2020 and Sep 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2020Break; Break
IT WAS REPORTED THAT THE SCREW HEAD BROKE ON INSERTION INTO FEMORAL CUTTING BLOCK. EVENT OCCURRED DURING USE, WHILE THE INSTRUMENT WAS INSIDE THE PATIENT. ALL THE PIECES WERE EXTRACTED WITHOUT INCIDENT. PROCEDURE WAS COMPLETED USING A SN BACK UP DEVICE. A SURGICAL DELAY OF LESS THAN 30 MINUTES WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 10597286 ↗
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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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