Chromic Gut SG-634Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521055872), received between Feb 1, 2019 and Feb 5, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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 16, 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.

• MalfunctionFeb 5, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE OF DENTAL EXTRACTIONS AND CLEANING, THE TEETH NEEDED EXTRACTIONS. IT WAS REPORTED THE 4 PACKS OF SUTURE WERE USED, 1 EACH USED ON UPPER AND LOWER ARCADE CAUSING GUMS TO BLEED. AND 2 OF 4 PACKS WERE USED CAUSED GUMS TO BLEED. IT WAS NOTED THE SUTURE UNRAVELED AND THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE, THE INCISION EXTENDED MORE THAN 1 INCH (2.54 CM). RE-SUTURING WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8304668 ↗
• MalfunctionFeb 1, 2019Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE OF DENTAL EXTRACTIONS AND CLEANING, THE TEETH NEEDED EXTRACTIONS. IT WAS REPORTED THE 4 PACKS OF SUTURE WERE USED, 1 EACH USED ON UPPER AND LOWER ARCADE CAUSING GUMS TO BLEED. AND 2 OF 4 PACKS WERE USED CAUSED GUMS TO BLEED. IT WAS NOTED THE SUTURE UNRAVELED AND THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE, THE INCISION EXTENDED MORE THAN 1 INCH (2.54CM). RE-SUTURING WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 8296639 ↗

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-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
• 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)