Chromic Gut SG-635Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521055896), received between Jan 17, 2018 and May 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2023Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER, ON A MAXILLA FACIAL CASE, TWO SUTURE BOXES HAD THREADS LOOPED UPON THEMSELVES. THE KNOT ON ONE OF THE SUTURES APPEARED BROKEN. THE THREAD WAS ALSO BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 16955770 ↗
• MalfunctionFeb 15, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING SURGICAL EXCISION FOR IMPACTED WISDOM TEETH, WHILE USING INTERRUPTED SUTURING TECHNIQUE, THE NEEDLE BENT AND DETACHED FROM THE THREAD. THE THREAD OF TWO MORE SUTURES BROKE. THE SURGEON USED ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327383 ↗
• MalfunctionFeb 15, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR IMPACTED WISDOM TEETH, WHILE SUTURING THE MUCOSA AFTER EXTRACTIONS THE THREAD BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 11327294 ↗
• MalfunctionJan 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE BREAKS. THEY NOTICE THAT THE SUTURE WAS BREAKING WHEN REMOVING IT FROM THE PACKAGE FOR TESTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7201104 ↗

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-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-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