Lock-Stitch™ Procedure Kit CM9500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868270376), received between Feb 21, 2023 and Mar 18, 2025 — classified as 2 malfunctions.

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

• MalfunctionMar 18, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGERY, THEN NITINOL NEEDLE GOT STUCK AT THE END OF THE SUTURE PASSER AT EXTENDED RANGE AND WOULD NOT GO BACK INTO THE LOADING AREA. IT WAS DETERMINED THAT NEEDLE FRACTURED OFF INSIDE PASSER. NEEDLE TIP HAD TO BE REMOVED WITH PLIERS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630369 ↗
• MalfunctionFeb 21, 2023Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407504 ↗