Hex-Lock® HLA3/4Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024015166), received between Aug 18, 2021 and Feb 13, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K011028, K013227); they may or may not involve this specific model.

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Unintended Movement

  IT WAS REPORTED THAT THE PROSTHESIS WAS PLACED AND TIGHTENED PERMANENTLY WITH 30 NCM AT TOOTH SITE #12. AFTER A MONTH, THE CROWN WAS MOVING. UNFORTUNATELY, IT WASN'T THE CROWN THAT WAS MOVING, BUT THE ABUTMENT. THE PATIENT RETURNED SEVERAL TIMES WITH THE SAME PROBLEM BUT THE ISSUE COULDN'T BE SOLVED. IN (B)(6), DENTIST REPLACED IT BECAUSE IT SEEMED LIKE THE FRICTION FIT CONNECTION WAS NOT FITTING CORRECTLY. PATIENT REFERRED PAIN. ABUTMENT WAS PLACED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2026. THIS EVENT IS CREATED TO REPRESENT THE FIRST LOOSENING.

  Patient problems: Pain

  MAUDE report 24330892 ↗
• MalfunctionJan 11, 2024Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495887 ↗
• MalfunctionJan 11, 2024Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491834 ↗
• MalfunctionJan 11, 2024Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491182 ↗
• MalfunctionAug 18, 2021Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335887 ↗
• MalfunctionAug 18, 2021Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335796 ↗
• MalfunctionAug 18, 2021Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335755 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011028, K013227. One submission often covers many models, so check the product and lot details in each record.

• Z-3206-2017 · Jul 10, 2017 · Terminated
  ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
• Z-2144-2014 · Jul 17, 2014 · Terminated
  Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.