Hex ToolRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 5 models of Hex Tool by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2018 and Sep 7, 2023 — classified as 19 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Hex Tool problems
Device problems
- Fracture12
- Separation Failure9
- Material Deformation4
- Failure to Osseointegrate3
- Detachment of Device or Device Component2
- Device-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Failure of Implant32
- No Consequences Or Impact To Patient9
- No Information7
- Osteopenia/ Osteoporosis3
- Insufficient Information2
- No Code Available2
- Unspecified Infection2
- Granuloma1
Hex Tool models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hex Tool HT1.25Accessories, Implant, Dental, Endosseous17 reports
- Hex Tool HT2.5Accessories, Implant, Dental, Endosseous16 reports
- Hex Tool HT3.0Accessories, Implant, Dental, Endosseous2 reports
- Hex Tool HT2.3Accessories, Implant, Dental, Endosseous1 report
- Hex Tool HT2.7Accessories, Implant, Dental, Endosseous1 report
Recent Hex Tool adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 7, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED
Patient problems: Failure of Implant
MAUDE report 17697631 ↗InjuryFeb 21, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16408238 ↗InjuryFeb 20, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16402448 ↗InjuryFeb 17, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16399252 ↗InjuryFeb 17, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16397403 ↗InjuryJan 10, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16128791 ↗InjurySep 5, 2022Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DEFORMATION WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 15355350 ↗InjuryMay 11, 2022Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURED.
Patient problems: Failure of Implant
MAUDE report 14366608 ↗InjuryMar 24, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 13891381 ↗InjuryMar 7, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant; Granuloma
MAUDE report 13685244 ↗InjuryOct 12, 2021Fracture; Fracture
PER COMPLAINT (B)(4), PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 12615130 ↗MalfunctionJul 14, 2021Fracture; Fracture
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12165873 ↗InjuryMay 26, 2021Separation Failure; Osseointegration Problem; Separation Failure; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11884379 ↗MalfunctionFeb 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11285556 ↗InjuryOct 22, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection; Vascular Dissection
MAUDE report 10716873 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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