STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL (REF 021.5412)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.1mm RC, SLA® 12mm, 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 appears in 9,748 adverse event reports, all of them injury reports, with no deaths. The reports mostly describe implants that fail to bond with the jawbone or later lose that bond, with some mentioning pain, swelling and infection around the implant. 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
- 9,862
- Deaths reported
- 0
- Injuries reported
- 9,862
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9,862 adverse event reports that list this exact device (DI 07630031707093), received between Sep 10, 2019 and Sep 30, 2026 — classified as 9,862 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8,698 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 Osseointegrate8,698
- Loss of Osseointegration957
- Adverse Event Without Identified Device or Use Problem180
- Fracture40
- Difficult to Insert11
- Difficult to Remove2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions6,250
- Fibrosis2,195
- Pain1,410
- Unspecified Infection878
- Inflammation542
- Swelling/ Edema426
- Tissue Damage383
- Hemorrhage/Blood Loss/Bleeding323
Recent adverse event reports
The 25 most recent of 9,862 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 25. On 2026(b)(6), 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 50950311 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(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. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950271 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950263 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 21. On 2026(b)(6), non-osseointegration was verified. Patient presented with fair oral hygiene. 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 50950217 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(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 and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50950204 ↗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 50950200 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50921949 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921870 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Pain
MAUDE report 50921777 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921771 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921648 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 50921351 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50921252 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Abscess; Fistula
MAUDE report 50921203 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50921091 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50921088 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50921062 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50921044 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920901 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920842 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920802 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920767 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920643 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920252 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920248 ↗
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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