BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMRecalls & reported problems across all models
Institut Straumann AG · 14 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39,692
- Deaths reported
- 0
- Injuries reported
- 39,692
- Recalls
- 0
We found 14 models of BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 39,692 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2019 and Sep 28, 2026 — classified as 39,692 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (25,840 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 BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM problems
Device problems
- Failure to Osseointegrate25,840
- Loss of Osseointegration10,224
- Adverse Event Without Identified Device or Use Problem2,870
- Difficult to Insert486
- Fracture337
- Separation Failure54
- Difficult to Remove42
- Unintended Movement35
Patient problems
- No Clinical Signs, Symptoms or Conditions15,080
- Fibrosis11,453
- Pain7,775
- Unspecified Infection6,053
- Tissue Damage5,543
- Inflammation3,597
- Hemorrhage/Blood Loss/Bleeding2,196
- Swelling/ Edema2,186
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM12,513 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM7,265 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM6,086 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM5,339 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM5,337 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,770 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM849 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM265 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM104 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM53 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
Recent BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM 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 50922021 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921885 ↗InjurySep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921802 ↗InjurySep 28, 2026Fracture
Patient problems: Fibrosis
MAUDE report 50921792 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921613 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50921604 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921590 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50921579 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50921578 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921491 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921451 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain; Unspecified Infection
MAUDE report 50921395 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50921360 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921179 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921160 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page