BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BL (REF 021.6310)Recalls & reported problems
Institut Straumann AG · Bone Level Implant D 4.8mm RC, SLActive® 10mm, Roxolid® Loxim™ · Class 2 · Implant
All models of BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann SLActive implant is placed in bone. Reports mostly describe the implant failing to bond with the surrounding bone, along with scar tissue, pain, and infection. There are 7,246 reports, with no deaths and 7,246 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 7,265
- Deaths reported
- 0
- Injuries reported
- 7,265
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,265 adverse event reports that list this exact device (DI 07630031707260), received between Sep 9, 2019 and Sep 28, 2026 — classified as 7,265 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,839 reports).
1 other recall cover devices cleared under the same FDA submission (K121131); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4,839
- Loss of Osseointegration1,625
- Adverse Event Without Identified Device or Use Problem652
- Difficult to Insert125
- Fracture25
- Separation Failure11
- Difficult to Remove6
- Therapeutic or Diagnostic Output Failure6
Patient problems
- No Clinical Signs, Symptoms or Conditions2,800
- Fibrosis2,055
- Pain1,507
- Unspecified Infection1,046
- Tissue Damage1,013
- Inflammation603
- Swelling/ Edema392
- Hemorrhage/Blood Loss/Bleeding376
Recent adverse event reports
The 25 most recent of 7,265 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921802 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921491 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50921360 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921160 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 50920427 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2022 in the patient's mouth. On (b)(6) 2026, 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 50920274 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920146 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920139 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50918740 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 50918657 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50918581 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2018 in ADA 30. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50918575 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825450 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50824690 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50823874 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807686 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 16. 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 50807343 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807150 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807147 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 46. 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 50807146 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806597 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806591 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 19, failure occurred upon insertion. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone and Ridge augmentation. 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 50806443 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hyperresponsive to stimuli; Pain
MAUDE report 50761050 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760556 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121131. One submission often covers many models, so check the product and lot details in each record.
- Z-0174-2015 · Sep 24, 2014 · TerminatedStraumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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