Hex-Lock® HLA3/5Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Hex-Lock (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024015180), received between May 6, 2023 and Feb 20, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399736 ↗MalfunctionDec 5, 2025Fracture; Fracture
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO A FRACTURE AT THE IMPLANT COLLAR. PATIENT ATTENDED AS AN EMERGENCY DUE TO LOSS OF THE CROWN ON IMPLANT 46. EXAMINATION REVEALED A FRACTURED PORTION OF THE IMPLANT COLLAR EMERGING AT THE GINGIVAL LEVEL, WITH THE ABUTMENT SCREW FRACTURED INSIDE THE IMPLANT. THE PATIENT REPORTED NO PAIN. PROCEDURE WAS NOT COMPLETED. THIS COMPLAINT REFERS TO THE SCREW ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725461 ↗MalfunctionAug 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW IN THE IMPLANT OF TOOTH SITE #34 (FDI) WAS FRACTURED. THE IMPLANT WAS REPORTED TO BE INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22887926 ↗MalfunctionAug 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22865017 ↗InjuryMay 6, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16883037 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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