ASTRA TECH Implant System® 24941Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 4.0 S - 9 mm · Class 2 · Implant
All models of ASTRA TECH Implant System (166)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ASTRA TECH OsseoSpeed dental implant is designed to fuse with the jawbone. Its 2,716 reports mostly describe the implant failing to fuse with the bone or losing its hold on it. Patient problems listed include implant failure, infection, inflammation and bone loss. The reports include 2,714 injuries and no deaths. 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
- 2,733
- Deaths reported
- 0
- Injuries reported
- 2,732
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,733 adverse event reports that list this exact device (DI 07392532108303), received between Jun 16, 2023 and Sep 30, 2026 — classified as 2,732 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,449 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1,449
- Loss of Osseointegration1,248
- Fracture33
- Crack5
- Damaged Thread5
- Malposition of Device3
- Insufficient Device Problem Information2
- Migration or Expulsion of Device2
Patient problems
- Failure of Implant2,669
- Unspecified Infection571
- Inflammation569
- Osteolysis215
- Pocket Erosion169
- Inadequate Osseointegration29
- No Clinical Signs, Symptoms or Conditions23
- Implant Pain8
Recent adverse event reports
The 25 most recent of 2,733 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949427 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948893 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945599 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936453 ↗InjurySep 29, 2026Damaged Thread
It was reported that a patient experienced a dental implant loss due to the fracture of a dental abutment screw.
Patient problems: Inadequate Osseointegration
MAUDE report 50936346 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss; periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50924304 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Patient reportedly had Infection and periimplantitis.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50912678 ↗InjurySep 24, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889702 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834335 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832587 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832505 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832503 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822749 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817601 ↗InjurySep 16, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792784 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50790637 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50780064 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779051 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50754217 ↗InjuryAug 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50498007 ↗InjuryAug 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497613 ↗InjuryAug 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50496380 ↗InjuryAug 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; Periimplantitis.
Patient problems: Inflammation
MAUDE report 50494940 ↗InjuryAug 28, 2026Loss of Osseointegration
Patient problems: Inflammation; Osteolysis
MAUDE report 50494693 ↗InjuryAug 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Osteolysis, Periimplantitis.
Patient problems: Inflammation; Osteolysis
MAUDE report 50494257 ↗
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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