Hex-Lock® ZOA342SRecalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024020740), received between May 20, 2024 and Jun 13, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Unintended Movement2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED A MOBILE PROSTHESIS DUE TO LOOSENINGS THAT FINALLY LED TO THE RETENTION SCREW BREAKAGE ON TOOTH SITE #36. PROCEDURE WAS COMPLETED WITH ANOTHER TIBASE WITH NO IMPACT ON THE PATIENT REPORTED. THIS EVENT REPRESENTS THE 1ST LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201203 ↗InjuryMar 31, 2025Fracture; Fracture
IT WAS REPORTED THAT THE CROWN WAS LOOSE AND THE ABUTMENT SCREW WAS FOUND TO BE BROKEN. THE IMPLANT WAS ALSO LOOSE, THEREFORE THE IMPLANT AND ABUTMENT WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730080 ↗InjuryMay 29, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19415304 ↗InjuryMay 20, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AT A FOLLOW UP VISIT, THE IMPLANT AT TOOTH LOCATION #16 (FDI) WAS REMOVED BECAUSE THE ABUTMENT ON THE IMPLANT HAD LOOSENED TO THE POINT THAT THE SCREWS HAD FALLEN OUT AND BROKEN, PREVENTING FORCEFUL LOCKING AND LEADING TO FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351511 ↗
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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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