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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.