ASTRA TECH Implant System® EV 25562Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Uni Abutment EV 4.2 - 1 mm · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532153730), received between Apr 6, 2026 and May 12, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153188 ↗InjuryApr 6, 2026Fracture
IN THIS EVENT IT IS REPORTED THAT A HEALING ABUTM.3.5/4.0-Ø6.5,6MM FRACTURED LEADING TO IMPLANT REMOVAL. THE SCREW FRACTURED AS WELL AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793059 ↗InjuryApr 6, 2026Fracture
IN THIS EVENT IT IS REPORTED THAT A HEALING ABUTM.3.5/4.0-Ø6.5,6MM FRACTURED LEADING TO IMPLANT REMOVAL. THE SCREW FRACTURED AS WELL AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793012 ↗InjuryApr 6, 2026Fracture
IN THIS EVENT IT IS REPORTED THAT A HEALING ABUTM.3.5/4.0-Ø6.5,6MM FRACTURED LEADING TO IMPLANT REMOVAL. THE SCREW FRACTURED AS WELL AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792985 ↗
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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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