STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL (REF 021.3410)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 3.3mm NC, SLA® 10mm, Ti, Loxim™ · Class 2 · Implant
All models of STRAUMANN BONE LEVEL TAPERED IMPLANT (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann Bone Level tapered dental implant has 11,012 adverse event reports, all counted as injuries, and no deaths. Most describe the implant failing to bond with the jawbone, and patients report pain, tissue scarring, infection or inflammation. A few reports describe fractures. 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
- 11,195
- Deaths reported
- 0
- Injuries reported
- 11,195
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11,195 adverse event reports that list this exact device (DI 07630031706676), received between Aug 29, 2019 and Sep 30, 2026 — classified as 11,195 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10,105 reports).
2 other recalls cover devices cleared under the same FDA submission (K140878); 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 Osseointegrate10,105
- Loss of Osseointegration887
- Fracture122
- Adverse Event Without Identified Device or Use Problem104
- Difficult to Insert5
- Unintended Movement2
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions7,871
- Fibrosis2,004
- Pain1,203
- Unspecified Infection685
- Inflammation635
- Swelling/ Edema458
- Hemorrhage/Blood Loss/Bleeding265
- Tissue Damage227
Recent adverse event reports
The 25 most recent of 11,195 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
The clinician reports the implant was inserted 2025(b)(6) in FDI 11. On 2026(b)(6), fracture of the implant was verified. Patient presented with bone type III and fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Inflammation. No further patient complications were reported.
Patient problems: Inflammation
MAUDE report 50950285 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 24. On 2026(b)(6), non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50950280 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 14. On 2026(b)(6), non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. 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 50950258 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in the patient's mouth. On 2026(b)(6), non-osseointegration was verified. Patient presented with bone type III and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50950205 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921944 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921750 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921672 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921671 ↗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 50921580 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921569 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50921369 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50921343 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921277 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50921257 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920922 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920913 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920898 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920847 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920730 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920722 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920245 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50920236 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50920227 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50920217 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920197 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140878. One submission often covers many models, so check the product and lot details in each record.
- Z-2935-2026 · Jul 16, 2026 · Open, ClassifiedStraumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Z-0117-2015 · Sep 19, 2014 · TerminatedStraumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or man
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.
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