C8 2-0 Bk Mono Nyl 18"/45cm 927BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848782009749), received between Mar 13, 2023 and Mar 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2023Detachment of Device or Device Component

  THE SUTURE BROKE AWAY FROM THE THREAD WHILE DR. (B)(6) WAS SUTURING. HE LOST THE SUTURE IN THE PATIENT AND HAD TO GO DIGGING FOR IT. HE GOT IT OUT BUT WANTS TO SWITCH BACK TO THE BRAND HE WAS USING PREVIOUSLY. ALL OF OUR DOCTORS ARE FAIRLY SKILLED SUTURING, DR. (B)(6) IS PROBABLY BY FAR THE MOST EXPERIENCED WITH PROBABLY 30 YEARS OF EXPERIENCE AND THIS WAS NOT USER ERROR. WE UNFORTUNATELY HAVE ALSO HAD ISSUE WITH THE SHARPOINT BRAND. MOSTLY BREAKAGE OF THE THREAD WHEN THEY ARE TYING OFF.

  Patient problems: Insufficient Information

  MAUDE report 16527317 ↗