S-ROM 2576-20-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295146773), received between Jan 14, 2019 and Apr 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE PRODUCT HAVE REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS WERE COMPLAINING ABOUT INSTRUMENT BEING DULL, ILLEGIBLE, AND GENERALLY WORN. THERE WILL BE MULTIPLE PAGES ON THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909394 ↗
• MalfunctionMar 23, 2026Illegible Information

  IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THIS DID NOT OCCUR INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665412 ↗
• MalfunctionApr 27, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THESE INSTRUMENTS HAVE EXCESSIVE WEAR AND ARE DIFFICULT TO READ. REP INDICATED "THAT THEY NEED TO BE REPLACED". NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10002030 ↗
• MalfunctionApr 6, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES ARE DAMAGED AND CAN¿T BE READ. NO LOT NUMBERS CAN BE READ. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928312 ↗
• MalfunctionFeb 27, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information; Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE DIFFICULT TO IMPOSSIBLE TO READ SIZING DUE TO WEAR AND TEAR AND NORMAL EVERYDAY USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765281 ↗
• MalfunctionMar 29, 2019Material Discolored; Material Deformation; Naturally Worn; Material Discolored; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE OFFICE SETS CANNOT READ THE NUMBERS. IT WAS WORN OUT. DID NOT EFFECT A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466439 ↗
• MalfunctionJan 14, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SLEEVE IS WORN OUT VERY BADLY AND WILL NOT SEAT ON INSERTION INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245825 ↗