Straumann TLX Implant SystemRecalls & reported problems across all models
Institut Straumann AG · 132 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10,425
- Deaths reported
- 0
- Injuries reported
- 10,425
- Recalls
- 0
We found 132 models of Straumann TLX Implant System by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 10,425 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2021 and Sep 28, 2026 — classified as 10,425 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7,468 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 Straumann TLX Implant System problems
Device problems
- Failure to Osseointegrate7,468
- Loss of Osseointegration1,745
- Adverse Event Without Identified Device or Use Problem1,109
- Difficult to Insert91
- Fracture15
- Separation Failure10
Patient problems
- No Clinical Signs, Symptoms or Conditions5,403
- Fibrosis3,866
- Pain1,918
- Unspecified Infection1,080
- Inflammation466
- Hemorrhage/Blood Loss/Bleeding359
- Swelling/ Edema346
- Hyperresponsive to stimuli199
Straumann TLX Implant System models
132 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM783 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM752 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM669 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM657 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM621 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM562 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM370 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM303 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM280 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM256 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM251 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM243 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM231 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM223 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM217 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM213 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM208 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM163 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM158 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM157 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM137 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM134 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM127 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM109 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM106 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM104 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM100 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM96 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM90 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM88 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM76 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM74 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM72 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM70 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM67 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM62 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM52 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM52 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM51 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM46 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM44 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM37 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM32 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM31 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM21 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Straumann TLX Implant System SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Straumann TLX Implant System SLA Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
Recent Straumann TLX 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 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921892 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921735 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli; Inflammation
MAUDE report 50921658 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921525 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920604 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920575 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920574 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50920548 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50920546 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920317 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920151 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920148 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50920116 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920088 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50919995 ↗
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
- ITI DENTAL IMPLANT SYSTEM60 models · 19,402 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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