STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL (REF 021.5314)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.1mm RC, SLActive® 14mm, Roxolid®, Loxim™ · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Straumann SLActive bone level tapered implant is placed in the jawbone to support a replacement tooth. Its 4,369 adverse event reports mostly describe implants that did not fuse with the jawbone or later lost that bond, with some describing pain, infection and scar tissue. The reports include no deaths and 4,369 injuries. 1 recall names this device: started in July 2026 and still open, it covers implants that may be 12mm long rather than their labeled length.
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
- 4,384
- Deaths reported
- 0
- Injuries reported
- 4,384
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,384 adverse event reports that list this exact device (DI 07630031707055), received between Sep 9, 2019 and Sep 28, 2026 — classified as 4,384 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,024 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 16, 2026Open, Classified
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
Z-2935-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate3,024
- Loss of Osseointegration717
- Adverse Event Without Identified Device or Use Problem552
- Difficult to Insert70
- Fracture18
- Separation Failure9
- Difficult to Remove5
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,817
- Fibrosis1,279
- Pain820
- Unspecified Infection692
- Tissue Damage514
- Inflammation339
- Swelling/ Edema213
- Hemorrhage/Blood Loss/Bleeding177
Recent adverse event reports
The 25 most recent of 4,384 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50921212 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921190 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920182 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Fistula; Inflammation; Unspecified Infection
MAUDE report 50920117 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50919403 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918610 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Fistula; Inflammation; Unspecified Infection
MAUDE report 50918546 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hyperresponsive to stimuli; Swelling/ Edema
MAUDE report 50826449 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806989 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50760158 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759136 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50738102 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 13. Details of surgery: Ridge augmentation. On 2026 (b)(6), non-osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50737412 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720347 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719283 ↗InjurySep 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 28. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50718933 ↗InjurySep 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2020 in FDI 21. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50718924 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 10, failure occurred upon insertion. Details of surgery: Primary stability not achieved. 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 50718863 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655296 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654564 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 24. 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 50481934 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 11. 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 50480516 ↗InjuryAug 24, 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. 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 50415492 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50414793 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414306 ↗
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-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.