S-ROM 2576-20-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295146766), received between Sep 29, 2017 and Apr 17, 2026 — classified as 10 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 10 most recent of 10 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 24909355 ↗
• 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 24665391 ↗
• MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES COULD NOT BE READ OR USED OR DAMAGED. NOT USED IN A CASE. LOT NUMBERS COULD NOT BE READ. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924116 ↗
• MalfunctionJul 1, 2019Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Scratched Material; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT THE SLEEVE IS BENT AND WILL NOT SLIDE OVER THE STEM. THE STEM WILL NOT ALLOW THE NECK SEGMENT TO SCREW IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748565 ↗
• 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 8466459 ↗
• MalfunctionMar 29, 2019Naturally Worn; 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 8466455 ↗
• MalfunctionApr 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT IDENTIFYING MARKINGS FOUND TO BE DAMAGED IN POST CLEANING INSPECTION, IT IS UNREADABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421581 ↗
• MalfunctionDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALL OF THE 10 SROM INSTRUMENTS WERE DEEMED TO BE UNUSABLE BECAUSE THE SIZE MARKINGS ARE NO LONGER VISIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7103843 ↗
• MalfunctionSep 29, 2017Appropriate Device Problem Term/Code Not Available; Illegible Information; Appropriate Device Problem Term/Code Not Available; Illegible Information

  IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.

  Patient problems: No Information

  MAUDE report 6903565 ↗
• MalfunctionSep 29, 2017Appropriate Device Problem Term/Code Not Available; Illegible Information; Appropriate Device Problem Term/Code Not Available; Illegible Information

  IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.

  Patient problems: No Information

  MAUDE report 6903536 ↗