ASTRA TECH Implant System® 24895Recalls & reported problems
Dentsply Implants Manufacturing GmbH · 20° UniAbutment 3.5/4.0 - 2 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 dental abutment is used with dental implants. The 24 reports mostly describe the abutment breaking, with no deaths and 16 injuries mentioned. No recalls name this device, and reports rose from 1 in the year before to 21 in the last year.
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
- 22
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07392532089978), received between Jan 24, 2024 and Apr 26, 2026 — classified as 14 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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
- Fracture22
- Loss of Osseointegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Failure of Implant6
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993888 ↗InjuryApr 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993529 ↗InjuryApr 8, 2026Fracture
CUSTOMER REPORTED FRACTURE OF ABUTMENT ON (B)(6) 2026, DIJXH617: WROTE AN EMAIL TO THE CUSTOMER ON THE DAY I REPORTED THIS ON (B)(6) 2026, TO ASK IF THE IMPLANTS IS STILL INTACT. NO REPLY AS OF TODAY AND HAVE SENT ANOTHER EMAIL TO FOLLOW UP. EXPLANT DATE IS DATE OF ABUTMENT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24819029 ↗InjuryMar 24, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE. THE IMPLANT CAN STILL BE LOADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675286 ↗InjuryMar 23, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE. THE IMPLANT WAS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661631 ↗InjuryMar 3, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE. THE IMPLANT IS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500227 ↗InjuryMar 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24479913 ↗InjuryMar 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24479793 ↗InjuryFeb 23, 2026Fracture
CUSTOMER REPORTED A FRACTURED ABUMENT. THE IMPLANT IS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423250 ↗InjuryFeb 23, 2026Fracture
CUSTOMER REPORTED A FRACTURED ABUTMENT. THE IMPLANT IS STILL LODABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423212 ↗MalfunctionFeb 16, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE ABUTMENT AND A ABUTMENT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343347 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 24061512 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 24060662 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24057267 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050380 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN ABUTMENT FRACTURE AND SUBSEQUENT IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846963 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN ABUTMENT FRACTURE AND SUBSEQUENT IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846960 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN ABUTMENT FRACTURE AND SUBSEQUENT IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846959 ↗InjuryDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN ABUTMENT FRACTURE AND SUBSEQUENT IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23846957 ↗InjuryJan 1, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21051014 ↗InjuryJun 13, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19526689 ↗InjuryJan 24, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18569923 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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