Straumann BLX 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
- 78,869
- Deaths reported
- 0
- Injuries reported
- 78,869
- Recalls
- 0
We found 60 models of Straumann BLX Implant System by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 78,869 adverse event reports in the FDA's MAUDE database, received between Aug 23, 2018 and Sep 28, 2026 — classified as 78,869 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (50,866 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 BLX Implant System problems
Device problems
- Failure to Osseointegrate50,866
- Loss of Osseointegration14,394
- Adverse Event Without Identified Device or Use Problem11,890
- Difficult to Insert1,462
- Fracture318
- Separation Failure210
- Difficult to Remove5
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions38,545
- Fibrosis27,248
- Pain15,040
- Unspecified Infection9,731
- Inflammation4,373
- Hemorrhage/Blood Loss/Bleeding3,192
- Swelling/ Edema3,105
- Hyperresponsive to stimuli2,187
Straumann BLX Implant System models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM6,711 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM5,491 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM4,920 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM4,328 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM3,637 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM3,490 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM3,450 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM3,244 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM3,243 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM2,772 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM2,563 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM2,442 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,882 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,879 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,803 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,616 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,519 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,463 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,397 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,357 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,324 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,273 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,243 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,205 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,200 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,169 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,061 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,031 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM985 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM921 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM776 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM691 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM615 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM564 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM494 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM490 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM482 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM481 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM423 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM416 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM385 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM350 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM323 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM273 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM230 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM212 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM192 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM160 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM134 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM93 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM93 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM92 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM84 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM68 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- Straumann BLX Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM33 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Straumann BLX Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
Recent Straumann BLX 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, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922024 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922012 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922005 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922001 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921999 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921997 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921937 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921928 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921921 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921912 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921906 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Pain; Swelling/ Edema
MAUDE report 50921881 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921879 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921860 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921824 ↗
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
- 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
- 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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