INHANCE 7205-30-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295538592), received between Apr 24, 2023 and Jun 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE GLENOID PIN WOULD NOT EASILY SLIDE THROUGH THE SIZER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365760 ↗
• MalfunctionJun 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECES GOT STUCK TOGETHER. THE PIN WOULD NOT PULL OUT OF SIZER HANDLE AFTER ATTEMPTING TO PUT IT INTO GLENOID THROUGH GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122669 ↗
• MalfunctionApr 24, 2023Break; Material Deformation; Break; Material Deformation

  THE SIZER HANDLE FOR THE ENHANCE SHOULDER SYSTEM HAD A BENT TAB ON THE CURVED END OF THE DEVICE AND WHEN THE HUMERAL AND GLENOID PINS WERE INSERTED DURING THE PROCEDURE, PLASTIC SHARDS WERE SEEN COMING OFF THE DEVICE. THE CONCERN WAS COULD THESE PLASTIC SHARDS/DEBRIS GET INTO THE OPEN SHOULDER JOINT AND NOT BE FOUND OR REMOVED THROUGH IRRIGATION THAT COULD CAUSE POST OPERATIVE COMPLICATIONS. THERE WAS A THREE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796365 ↗
• MalfunctionApr 24, 2023Break; Material Deformation; Break; Material Deformation

  THE SIZER HANDLE FOR THE INHANCE SHOULDER SYSTEM HAD A BENT TAB ON THE CURVED END OF THE DEVICE AND WHEN THE HUMERAL AND GLENOID PINS WERE INSERTED DURING THE PROCEDURE, PLASTIC SHARDS WERE SEEN COMING OFF THE DEVICE. THE CONCERN WAS COULD THESE PLASTIC SHARDS/DEBRIS GET INTO THE OPEN SHOULDER JOINT AND NOT BE FOUND OR REMOVED THROUGH IRRIGATION THAT COULD CAUSE POST OPERATIVE COMPLICATIONS. THERE WAS A TWO MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796300 ↗