Plain Gut SG-828Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521056114), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K142656, K885018); they may or may not involve this specific model.

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.

• InjuryJul 31, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A SEPTOPLASTY WHEN THE SURGEON WAS TAKING A PASS THROUGH THE NOSE WITH THE NEEDLE, THE SURGEON PULLED IT OUT AND THE NEEDLE CAME OFF THE STRAND. THEY OPENED ANOTHER STRAND AND AFTER THE FIRST PASS, THE NEEDLE BROKE BECAME STUCK IN THE NOSE. THEY TRIED TO LOCATE THE NEEDLE FOR AN HOUR AND EVENTUALLY CALLED ON X-RAY TO HELP LOCATE IT, WHICH WORKED AND THEY LOCATED IT AND REMOVED IT.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8846778 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142656, K885018. One submission often covers many models, so check the product and lot details in each record.

• Z-1389-2023 · Mar 1, 2023 · Open, Classified
  Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
• Z-1390-2023 · Mar 1, 2023 · Open, Classified
  Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
• Z-1388-2023 · Mar 1, 2023 · Open, Classified
  Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (G