Straumann® BLC and TLC Implants SLA Roxolid TL (REF 035.6712S)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630031765956), received between Aug 10, 2026 and Aug 10, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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, 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Failure to Osseointegrate

  The clinician reports the implant was inserted (b)(6) 2025 in ADA 3. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Swelling. No further patient complications were reported.

  Patient problems: Swelling/ Edema

  MAUDE report 50199698 ↗
• InjuryAug 10, 2026Failure to Osseointegrate

  The clinician reports the implant was inserted 2025 (b)(6) in ADA 3. Details of surgery: Implant surface not completely covered with bone. On 2026 (b)(6), non-osseointegration was verified. Patient presented with fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Swelling. No further patient complications were reported.

  Patient problems: Swelling/ Edema

  MAUDE report 50197404 ↗