ASTRA TECH Implant System® 24939Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 4.0 S - 6 mm · Class 2 · Implant
All models of ASTRA TECH Implant System (166)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech OsseoSpeed dental implant is placed in the jawbone. Most of its 1,078 reports describe the implant failing to bond with the bone or being lost after placement, and some mention infection or bone loss. The reports include no deaths and 1,078 injuries. 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
- 1,113
- Deaths reported
- 0
- Injuries reported
- 1,113
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,113 adverse event reports that list this exact device (DI 07392532108280), received between May 11, 2023 and Sep 30, 2026 — classified as 1,113 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (565 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate565
- Loss of Osseointegration542
- Fracture8
- Off-Label Use4
- Damaged Thread2
- Malposition of Device2
- Migration or Expulsion of Device2
Patient problems
- Failure of Implant1,077
- Unspecified Infection198
- Inflammation177
- Pocket Erosion77
- Osteolysis65
- Inadequate Osseointegration23
- No Clinical Signs, Symptoms or Conditions7
- Implant Pain2
Recent adverse event reports
The 25 most recent of 1,113 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50949022 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50946036 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926461 ↗InjurySep 20, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833707 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691848 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690596 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to Mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50689501 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50688877 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50680135 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50679511 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50678908 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50678321 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50678036 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50677628 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50677518 ↗InjurySep 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50677035 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to Mobility and Infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50676055 ↗InjurySep 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50675720 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50675275 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50674810 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50674678 ↗InjurySep 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50674469 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50674262 ↗InjurySep 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss; non-primary stability.
Patient problems: Inadequate Osseointegration
MAUDE report 50674057 ↗InjurySep 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50673860 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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