Hex-Lock® ZOA441SRecalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024020771), received between Jul 2, 2020 and Jul 9, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Unintended Movement2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2020Unintended Movement; Unintended Movement
DOCTOR REPORTED LOOSENING OF ABUTMENT ZOA441S AT TOOTH SIDE 36 TWICE. A NEW SCREW AND A NEW CROWN HAVE BEEN USED TO COMPLETE THE PROCEDURE.
Patient problems: No Information
MAUDE report 10249554 ↗MalfunctionJul 2, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED LOOSENING OF THE ABUTMENT. NEW SCREW WAS PLACED.
Patient problems: No Information
MAUDE report 10224030 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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