Ceramill® Zolid Zolid fx ML 0/A1 98x20 NRecalls & reported problems
Amann Girrbach AG · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI E4947617781), received between May 14, 2021 and May 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2021Device Contamination with Chemical or Other Material; Material Integrity Problem
SUMMARY: DURING PRODUCTION, BLANKS WITH SURFACE INCLUSIONS WERE DISCOVERED AFTER SINTERING IN ONE ORDER. AFTER AN EDX ANALYSIS WAS PERFORMED ON THE INCLUSIONS, IT WAS CONFIRMED THAT THEY WERE METALLIC PARTICLES. THIS CONFIRMED THE SUSPICION THAT THE PARTICLES ORIGINATED FROM THE PRESS ITSELF, CAUSED BY A CRASH ON THE PRESS, WHICH WAS DOCUMENTED. THUS, AFFECTED ORDERS COULD BE IDENTIFIED AND RECHECKED. FROM THE AFFECTED BATCHES, 1756 BLANKS COULD STILL BE BLOCKED BEFORE DELIVERY. ACCORDING TO THE SYSTEM, 358 BLANKS HAVE ALREADY BEEN DELIVERED TO INTERMEDIATE STORAGE. OF THESE, 79 BLANKS HAVE ALREADY BEEN DELIVERED TO CUSTOMERS. RISK ASSESSMENT & DECISION: IN THE CASE OF THE AFFECTED DELIVERED PRODUCTS, THERE IS A POTENTIAL RISK OF CONTAMINATION BY METALLIC FOREIGN PARTICLES, WHICH COULD INFLUENCE THE ESTHETIC AS WELL AS MECHANICAL PROPERTIES OF THE FINAL PRODUCT (DENTAL RESTORATION). THE PROBABILITY OF DETECTION DURING PROCESSING IS CONSIDERED TO BE VERY GOOD. NEVERTHELESS, THERE IS NO FULLY COMPREHENSIVE SECURITY FOR THIS. IN ADDITION, PRODUCT CONFORMITY CANNOT BE GUARANTEED. THEREFORE, ALL PRODUCED AND POTENTIALLY CONTAMINATED PRODUCTS MUST BE SCRAPPED. PRODUCTS THAT HAVE ALREADY
Patient problems: Insufficient Information
MAUDE report 11824906 ↗
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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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