ZUK 00584302500Recalls & reported problems
Smith & Nephew, Inc. · ZUK Removal Hook · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556621387), received between Aug 5, 2019 and Aug 12, 2020 — classified as 4 malfunctions.
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 Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2020Break; Break
IT WAS REPORTED THAT DURING TKA PROCEDURE THE TIP OF THE REMOVAL HOOK BROKE OFF OUTSIDE THE PATIENT. NO DELAY OR HARM TO THE PATIENT REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10396495 ↗MalfunctionJun 26, 2020Break; Break
IT WAS REPORTED THAT THE REMOVAL HOOK TIP BROKE OFF DURING SURGERY, OUTSIDE THE PATIENT. NO PIECE FELL INSIDE THE PATIENT. THERE WAS NO DELAY IN THE CASE. THE PROCEDURE WAS FINISHED WITH SAME S&N BACKUP DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10199941 ↗MalfunctionOct 14, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING A SURGERY. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. NO S&N BACKUP WAS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9187124 ↗MalfunctionAug 5, 2019Break; Break
IT WAS REPORTED THAT WHILE REMOVING THE DISTAL FEMORAL CUT BLOCK, THE REMOVAL HOOK BROKE. THIS HAPPENED DURING SURGERY. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8859659 ↗
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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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