Tapered Screw-Vent® Implant System HLA4GRecalls & reported problems

All models of Tapered Screw-Vent Implant System (28)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 8
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024015234), received between Dec 5, 2021 and Feb 27, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture6
Unintended Movement2
Premature Separation1
Separation Failure1

Patient problems

No Clinical Signs, Symptoms or Conditions7
Inflammation1
Pain1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 27, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468971 ↗
InjuryFeb 26, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461869 ↗
MalfunctionAug 28, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916749 ↗
MalfunctionAug 27, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909994 ↗
MalfunctionAug 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A CHIEF COMPLAINT OF A LOOSE IMPLANT RESTORATION. AGAIN, WE DISCOVERED THAT THE ENGAGING PORTION OF THE CAST TO GOLD ABUTMENT HAD FRACTURED. THE IMPLANT APPEARS STABLE AND THIS APPEARS TO BE A RECURRENT PROSTHETIC ISSUE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.
Patient problems: Inflammation; Pain
MAUDE report 22889884 ↗
MalfunctionDec 14, 2022Fracture; Separation Failure; Premature Separation; Fracture; Separation Failure; Premature Separation
DOCTOR REPORTED THAT HLA4G ABUTMENT DISENGAGED FROM 6 HEXAGON, PROBABLY IT IS A MATERIAL DEFECT. THE IMPLANT WAS REMOVED. THE IMPLANT WAS NOT DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15980284 ↗
MalfunctionDec 2, 2022Unintended 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 15907713 ↗
MalfunctionDec 5, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT SCREW LOOSENED IN THE PATIENT'S MOUTH AT SITE #36 AND WAS RETIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12931385 ↗

Device details

UDI-DI	`00889024015234`
Brand	Tapered Screw-Vent® Implant System
Model	HLA4G
Company	ZimVie US Corp LLC
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 15, 2026

Device type (GMDN): Dental implant suprastructure, permanent, preformed

A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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