Infinity Internal Hex SystemRecalls & reported problems across all models
Ace Surgical Supply CO., Inc. · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,257
- Deaths reported
- 0
- Injuries reported
- 2,256
- Recalls
- 0
We found 24 models of Infinity Internal Hex System by Ace Surgical Supply CO., Inc. in the FDA's device registry (GUDID). Together they are named in 2,257 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2015 and Jun 9, 2026 — classified as 2,256 injuries, 1 malfunction.
The most frequently reported specific device problem is “Osseointegration Problem” (1,754 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
Reports received per month, all models
Most reported Infinity Internal Hex System problems
Device problems
- Osseointegration Problem1,754
- Failure to Osseointegrate1,583
- Insufficient Device Problem Information159
- Loss of Osseointegration95
- Patient Device Interaction Problem62
- Therapeutic or Diagnostic Output Failure12
- Device Issue7
- Appropriate Device Problem Term/Code Not Available6
Patient problems
- Failure of Implant2,243
- Pain556
- Unspecified Infection194
- Swelling72
- Numbness70
- Fistula58
- Swelling/ Edema9
- Insufficient Information6
Infinity Internal Hex System models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infinity Internal Hex System 203710IMPLANT, ENDOSSEOUS, ROOT-FORM415 reports
- Infinity Internal Hex System 204110IMPLANT, ENDOSSEOUS, ROOT-FORM329 reports
- Infinity Internal Hex System 204710IMPLANT, ENDOSSEOUS, ROOT-FORM236 reports
- Infinity Internal Hex System 203711IMPLANT, ENDOSSEOUS, ROOT-FORM161 reports
- Infinity Internal Hex System 204108IMPLANT, ENDOSSEOUS, ROOT-FORM152 reports
- Infinity Internal Hex System 204708IMPLANT, ENDOSSEOUS, ROOT-FORM142 reports
- Infinity Internal Hex System 203708IMPLANT, ENDOSSEOUS, ROOT-FORM139 reports
- Infinity Internal Hex System 204111IMPLANT, ENDOSSEOUS, ROOT-FORM138 reports
- Infinity Internal Hex System 204106IMPLANT, ENDOSSEOUS, ROOT-FORM85 reports
- Infinity Internal Hex System 203713IMPLANT, ENDOSSEOUS, ROOT-FORM75 reports
- Infinity Internal Hex System 205110IMPLANT, ENDOSSEOUS, ROOT-FORM67 reports
- Infinity Internal Hex System 204711IMPLANT, ENDOSSEOUS, ROOT-FORM63 reports
- Infinity Internal Hex System 204113IMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- Infinity Internal Hex System 205108IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- Infinity Internal Hex System 205111IMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- Infinity Internal Hex System 205106IMPLANT, ENDOSSEOUS, ROOT-FORM33 reports
- Infinity Internal Hex System 204713IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Infinity Internal Hex System 205113IMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Infinity Internal Hex System 204116IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Infinity Internal Hex System 205116IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Infinity Internal Hex System 214711IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Infinity Internal Hex System 214710IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Infinity Internal Hex System 214708IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Infinity Internal Hex System 214713IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Infinity Internal Hex System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate; No Apparent Adverse Event
InjuryApr 3, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 6, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT #30 SPINNED WITH SLIGHT INFECTION.
Patient problems: Failure of Implant
MAUDE report 22158953 ↗InjuryJun 6, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 6, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT #9 SPINNED WITH SLIGHT INFECTION.
Patient problems: Failure of Implant
MAUDE report 22158918 ↗InjuryApr 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 4, 2025Loss of Osseointegration; Loss of Osseointegration
Other Ace Surgical Supply CO., Inc. products
All Ace Surgical Supply CO., Inc. devices →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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