ZUK 00584305200Recalls & reported problems
Smith & Nephew, Inc. · ZUK Tray/Articular Surface Inserter Bottom · Class 1
All models of ZUK (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556621653), received between Aug 22, 2018 and Jan 11, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (4 reports).
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
- Break4
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2021Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, TRAY/ARTICULAR SURFACE INSERTER BOTTOM DEVICE BROKE WHEN INSERTING POLY. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11151035 ↗InjuryNov 10, 2020Break; Break
IT WAS REPORTED THAT THE TRAY/ARTICULAR SURFACE INSERTER BOTTOM BROKE DURING A TKA PROCEDURE AND INSIDE THE PATIENT. NO SURGICAL DELAYS REPORTED. NO INFORMATION ABOUT HOW THE PROCEDURE WAS FINISHED WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10815774 ↗InjuryNov 3, 2020Break; Break
IT WAS REPORTED THAT, DURING A TKA, THE INSERTER BROKE WHILE TRYING TO SEAT THE POLY. ALL PIECES WERE RETRIEVED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10780702 ↗InjuryAug 22, 2018Break; Break
IT WAS REPORTED THAT INSERTER BROKE DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH COMPETITOR'S DEVICE.
Patient problems: No Information
MAUDE report 7806815 ↗
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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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