Chromic Gut SG-5637GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521055698), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryApr 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 11 WEEKS AFTER AN OPEN PROCEDURE ON A CLUBBED FEET WHERE MORE THAN 20 SUTURES WERE USED, DURING POST-OPERATIVE VISITS, THE SURGEON NOTICED THAT THE SUTURE DID NOT DISSOLVE ON ITS OWN. THE SURGEON HAD TO BRING THE PATIENT BACK TO THE OPERATING ROOM TO HAVE THE SUTURE REMOVED AND TO COMPLETE UNDER ANESTHESIA. THIS DELAYED FURTHER CARE AND FITTING FOR BRACES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14044887 ↗

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-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
• 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)