Sofsilk GS-833Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521085244), received between Mar 29, 2017 and Dec 29, 2025 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (28 reports).

13 other recalls cover devices cleared under the same FDA submission (K981128); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC J TUBE PLACEMENT, THERE WAS NEEDLE DETACHMENT WHILE SUTURING AFTER PATIENT INCISION, WITH MINIMAL PRESSURE APPLIED. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907439 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A RIGHT BELOW KNEE AMPUTATION OPEN PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING DURING LIGATION OF BLOOD VESSELS. TWO SUTURES WERE REPORTED AS DEFECTIVE DURING THE SAME EVENT WITH THE SAME PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL KNOTS WERE TIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637014 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A RIGHT BELOW KNEE AMPUTATION OPEN PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING DURING LIGATION OF BLOOD VESSELS. TWO SUTURES WERE REPORTED AS DEFECTIVE DURING THE SAME EVENT WITH THE SAME PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL KNOTS WERE TIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629346 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC, THE TWO NEEDLE DETACHED AND FELL INTO THE PATIENT CAVITY, THE NEEDLES WERE REMOVED FROM THE PATIENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302459 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC, THE TWO NEEDLE DETACHED AND FELL INTO THE PATIENT CAVITY, THE NEEDLES WERE REMOVED FROM THE PATIENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301786 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL LAVAGE PROCEDURE, THE TWO NEEDLE DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273889 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL LAVAGE PROCEDURE, THE TWO NEEDLE DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273757 ↗
• MalfunctionJan 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE THREAD OF BOTH DEVICE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528281 ↗
• MalfunctionJan 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE THREAD OF BOTH DEVICE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528264 ↗
• MalfunctionDec 22, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT BASILIC VEIN EXCISION OPEN PROCEDURE, WHEN CLOSURE OF VESSEL, THE THREAD BROKE. ADDITIONAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383253 ↗
• MalfunctionDec 22, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT BASILIC VEIN EXCISION OPEN PROCEDURE, WHEN CLOSURE OF VESSEL, THE THREAD BROKE. ADDITIONAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383214 ↗
• MalfunctionDec 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT BASILIC VEIN EXCISION OPEN PROCEDURE, WHEN CLOSURE OF VESSEL, THE THREAD BROKE. ADDITIONAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374818 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN SUTURING THE MESENTERY VIA THE RUNNING STITCH TECHNIQUE, THE NEEDLE SNAPPED OFF THE SUTURE AND FELL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, THE NEEDLE WAS IDENTIFIED AND RETRIEVED. IT WAS NOTED THAT AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127874 ↗
• MalfunctionOct 2, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY OPEN PROCEDURE, THE DEVICE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851923 ↗
• MalfunctionSep 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AFTER 30 MINUTES OF BEING REMOVED FROM THE PACKAGING VIA RUNNING STITCH TECHNIQUE, THE SWAGED NEEDLE BROKE OFF FROM THE STRAND. THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT, AND WAS ABLE TO RETRIEVE THE NEEDLE. IT OCCURRED ON TWO DIFFERENT SUTURES. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700980 ↗
• MalfunctionApr 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING DIALYSIS LINE PLACEMENT, THE DIALYSIS CATHETER KIT SUTURES WERE RIPPING. A 2.0 NON-ABSORBABLE SUTURE NEEDLE WAS USED; WHEN ATTEMPTING TO PULL BACK THE NEEDLE, IT BROKE OFF. NO DEVICE COMPONENTS FELL INTO THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714427 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE. A COMPETITORS SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547452 ↗
• MalfunctionOct 18, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621547 ↗
• MalfunctionOct 14, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OFF AND BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15610429 ↗
• MalfunctionAug 18, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE BROKE. ADDITIONAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249795 ↗
• MalfunctionMay 31, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE WHILE SUTURING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549727 ↗
• MalfunctionJan 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE BROKE INTO 2 PIECES. BROKEN PIECES WERE ACCOUNTED FOR BY THE SURGEON AND SCRUB TECH. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13299117 ↗
• MalfunctionDec 28, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLOSTOMY, THE TIP OF THE NEEDLE BROKE. ANOTHER STRAND WAS RETRIEVED TO COMPLETE THE SURGICAL STEP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13092966 ↗
• MalfunctionDec 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE STAPLER, DURING OPEN CRANIOTOMY, PART OF THE NEEDLE BROKE IN TWO PIECES. ALL PARTS OF THE NEEDLE WERE LOCATED THROUGH VISUAL INSPECTION AND RETRIEVED USING FORCEPS. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965321 ↗
• MalfunctionOct 28, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, AS THE DEVICES WERE ABOUT TO BE USED FOR CONTINUOUS SUTURING, IT WAS NOTICED THAT THE COLOR LOOKED DIFFERENT AND THE SUTURE BROKE EASILY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715092 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981128. One submission often covers many models, so check the product and lot details in each record.

• Z-1697-2024 · Jan 25, 2024 · Open, Classified
  Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation an
• Z-0845-2024 · Dec 21, 2023 · Open, Classified
  Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X
• Z-1176-2023 · Dec 2, 2022 · Open, Classified
  Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75C
• Z-2811-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 18" BLACK CV-25 DT non-absorbable silk sutures GS33M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the c
• Z-2813-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the
• Z-2812-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures GS43M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2819-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE non-absorbable braided nylon sutures S196 Sofsilk is intended for use in general soft tissue approximation and/or ligation, inclu
• Z-2814-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS46M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the c
• Z-2817-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 2/0 30" BLACK V-20 DT non-absorbable braided nylon sutures GS66M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2810-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon sutures CS10M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use i
• Z-2816-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon sutures GS63M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2815-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH non-absorbable silk sutures GS62M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in
• Z-2818-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, includ