Z900LRecalls & reported problems
Nakanishi Inc. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264572683), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
InjuryMar 2, 2026Detachment of Device or Device Component
ON (B)(6) , 2026, (B)(6) BECAME AWARE OF A PATIENT'S ACCIDENTAL INGESTION OF A DENTAL BUR THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON MAY 8, 2024. - A DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z900L HANDPIECE (SERIAL NO. (B)(6). - DURING THE PROCEDURE, THE DENTAL OFFICE WAS AWARE THAT THE PATIENT HAD SWALLOWED THE BUR. - THE DENTIST ADVISED THAT THE PATIENT VISIT THE ER TO HAVE AN X-RAY AS A PRECAUTION. THE PATIENT IS REPORTED TO HAVE VISITED THE ER AND WAS RELEASED AFTER THEY COULD NOT LOCATE THE BUR IN THE X-RAY IMAGES. - THE PATIENT DID NOT COMPLAIN OF ANY ISSUES AT THE TIME OF THE EVENT AND DID HAVE A FOLLOW-UP VISIT WITH THE DENTIST AFTER THE EVENT AT THE DENTAL OFFICE WITH NO ISSUES. - THE DENTAL OFFICE REPORTED THAT AFTER SOME TIME HAD PASSED THE PATIENT HAD GONE TO A SECOND ER AND AT THAT TIME SOMETHING WAS FOUND. THE DENTAL OFFICE HAS NOT DISCLOSED WHAT WAS FOUND OR WHAT THE NATURE OF THEIR PATIENT'S SECOND VISIT TO THE ER WAS FOR. DUE TO THE LACK OF INFORMATION PROVIDED, IT IS NOT CLEAR IF THE VISIT WAS DUE TO THE BUR THAT WAS SWALLOWED IN (B)(6) 2024 OR IF IT
Patient problems: Insufficient Information
MAUDE report 24492415 ↗
Other Handpiece, air-powered, dental devices
- Henry Schein Maxima 5702660Henry Schein, Inc. · Handpiece, air-powered, dental15 reports
- Midwest T1 Energo 6814680SIRONA Dental Systems GmbH · Handpiece, air-powered, dental14 reports
- Midwest® E Plus 875205SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental12 reports
- HENRY SCHEIN 5701072Henry Schein, Inc. · Handpiece, air-powered, dental11 reports
- Midwest® E mini 875101SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental10 reports
- Midwest® E Pro 875105SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental10 reports
- Maxima 5702094Henry Schein, Inc. · Handpiece, air-powered, dental8 reports
- Midwest Tradition® 790344SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.