ANKYLOS® 31033623Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Insert for Prosthetic Ratchet for Abutments with Snap Attachment · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532218965), received between Feb 17, 2026 and Jul 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE RATCHET INSERT FOR BALL ABUTMENTS BROKE. THE SURGERY COULD BE FINISHED BY USING ANOTHER TOOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25746632 ↗MalfunctionFeb 17, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT WHEN TURNING THE ANKYLOS INSERT FOR PROSTHETIC RATCHET TO REMOVE THE ABUTMENT, THE PIECES COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362266 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.