ITI DENTAL IMPLANT SYSTEMRecalls & reported problems across all models
Institut Straumann AG · 60 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19,402
- Deaths reported
- 0
- Injuries reported
- 19,402
- Recalls
- 0
We found 60 models of ITI DENTAL IMPLANT SYSTEM by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 19,402 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2018 and Sep 30, 2026 — classified as 19,402 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (11,046 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 ITI DENTAL IMPLANT SYSTEM problems
Device problems
- Failure to Osseointegrate11,046
- Loss of Osseointegration7,779
- Fracture601
- Adverse Event Without Identified Device or Use Problem124
- Unstable17
- Difficult to Insert16
- Unintended Movement14
- Separation Failure6
Patient problems
- No Clinical Signs, Symptoms or Conditions8,851
- Fibrosis4,277
- Tissue Damage3,413
- Pain3,103
- Unspecified Infection3,035
- Hemorrhage/Blood Loss/Bleeding1,172
- Inflammation1,162
- Swelling/ Edema754
ITI DENTAL IMPLANT SYSTEM models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,168 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,704 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,152 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM965 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM895 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM882 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM849 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM718 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM675 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM604 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM579 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM547 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM537 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM491 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM456 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM449 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM395 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM369 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM330 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM312 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM270 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM268 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM252 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM216 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM215 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM207 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM193 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM182 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM182 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM174 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM167 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM166 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM148 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM143 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM141 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM134 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM133 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM127 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM106 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM104 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM87 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM76 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM68 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM62 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM61 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM58 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM51 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM50 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM32 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM31 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- ITI Dental Implant System SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
Recent ITI DENTAL IMPLANT SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2023(b)(6) in FDI 27. On 2026(b)(6), loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950327 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50921890 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921835 ↗InjurySep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921409 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921391 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920838 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920833 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920826 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920789 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50920573 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919630 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919462 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919358 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919357 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919355 ↗
Other Institut Straumann AG products
- Straumann Dental Implant System Roxolid SLA Impl.80 models · 377,342 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT39 models · 308,650 reports · 1 recall
- STRAUMANN DENTAL IMPLANT SYSTEM128 models · 98,339 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM42 models · 80,770 reports
- Straumann BLX Implant System60 models · 78,869 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM14 models · 39,692 reports
- Straumann BLC and TLC Implants153 models · 20,568 reports
- Small Diameter Implant System5 models · 16,170 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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