KINCISE 200003001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07612334268761), received between Oct 31, 2025 and Sep 4, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616290 ↗
• MalfunctionSep 2, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573047 ↗
• MalfunctionAug 27, 2026Material Fragmentation

  It was reported that during an unspecified surgical procedure, it was discovered that the emphasys str shell/liner impactor device was broken. It was not reported if there were any delays to the surgical procedure or if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482488 ↗
• MalfunctionJan 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ADAPTOR DEVICE WOULD NOT DISENGAGE FROM THE GUN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192033 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE STRAIGHT CUP IMPACTOR DEVICE WOULD NOT DISENGAGE FROM THE IMPACTOR DEVICE AFTER CUP IMPACTION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437132 ↗