Hex Tool Long HT1.25LRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307119661), received between May 14, 2022 and May 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Device problems

Material Deformation1

Patient problems

Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 14, 2022Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 14403624 ↗

Device details

UDI-DI	`10841307119661`
Brand	Hex Tool Long
Model	HT1.25L
Company	Implant Direct Sybron Manufacturing LLC
Product code	NDP · Accessories, Implant, Dental, Endosseous
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 5, 2018

Device type (GMDN): Surgical screwdriver, reusable

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Other Accessories, Implant, Dental, Endosseous devices

N/A 68015189
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
388 reports
N/A 68015191
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
319 reports
N/A 68015193
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
283 reports
N/A 68015187
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
266 reports
N/A 68015188
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
185 reports
N/A 68015192
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
159 reports
N/A 68015190
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
147 reports
NobelReplace® 37045
Nobel Biocare AB · Accessories, implant, dental, endosseous
2 recalls0 reports

All Accessories, Implant, Dental, Endosseous 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.

How reports and recalls are matched · Editorial policy · Report an error on this page