ASTRA TECH Implant System® 24942Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 4.0 S - 11 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 Dentsply Astra Tech OsseoSpeed dental implant is placed in the jawbone. Its 2,408 reports are all injury reports, mostly describing the implant coming loose or not bonding with the bone, and mention inflammation, infection and bone loss around the implant. Some mention fractures. There are no deaths, and 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
- 2,440
- Deaths reported
- 0
- Injuries reported
- 2,440
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,440 adverse event reports that list this exact device (DI 07392532108310), received between Jun 16, 2023 and Sep 30, 2026 — classified as 2,440 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,203 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
- Loss of Osseointegration1,203
- Failure to Osseointegrate1,165
- Fracture58
- Damaged Thread11
- Insufficient Device Problem Information4
- Malposition of Device3
- Crack2
- Overfill1
Patient problems
- Failure of Implant2,407
- Inflammation557
- Unspecified Infection525
- Osteolysis230
- Pocket Erosion159
- No Clinical Signs, Symptoms or Conditions22
- Inadequate Osseointegration13
- Implant Pain7
Recent adverse event reports
The 25 most recent of 2,440 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 50950527 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948579 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with progressive bone loss and periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50947628 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50936376 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Concomitant product: Standard abutment Astra.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932860 ↗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 50932457 ↗InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927280 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50924255 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834769 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832709 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832512 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832511 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832496 ↗InjurySep 18, 2026Fracture
Patient problems: Inadequate Osseointegration
MAUDE report 50828251 ↗InjurySep 18, 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 50817340 ↗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 50813452 ↗InjurySep 18, 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 50813424 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50809807 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808684 ↗InjurySep 17, 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 50806456 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50805913 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805084 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant failure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805014 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50791338 ↗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 50776648 ↗
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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