Hex-Lock® HLA5/6Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024015241), received between May 18, 2023 and May 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
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.
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT PATIENT CAME IN WITH LOOSE CROWN AT TOOTH #18. COULD NOT GET CROWN OFF. CROWN WAS SUPER LOOSE AND ROTATING COMPLETELY. WHEN REMOVED, ABUTMENT CAME LOOSE WITH CROWN. HEALING ABUTMENT WAS PUT BACK ON. THE CROWN STILL CEMENTED TO ABUTMENT. THE ABUTMENT SCREW LOOSENED CAME OUT. LOOSENING WAS DISCOVERED BECAUSE IT WAS NOT VERY LITTLE LOOSE, AND PATIENT DID NOT WANT HOLE DRILLED THROUGH CROWN. WHEN THEY CAME BACK THE ABUTMENT WAS COMPLETELY LOOSE AND CAME OUT EASILY. REMOVED AND PLACED WITH HEALING ABUTMENT. LOCATION UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16956248 ↗
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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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