Sofsilk GS-832Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521085220), received between Jul 22, 2021 and Jan 7, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE GS-832 SOFSILK SUTURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE FELL INTO THE PATIENT CAVITY BUT WAS SUCCESSFULLY RETRIEVED USING NEEDLE PORTS. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090269 ↗
• MalfunctionSep 6, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15364208 ↗
• MalfunctionSep 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF THE DEVICE POPPED OFF. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 15363290 ↗
• MalfunctionApr 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 14145735 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SURGERY, WHEN THE SURGEON PUT NEEDLE ON NEEDLE HOLDER, THE SUTURE BROKE. A PIECE FELL ON THE FLOOR THAT CHARGE NURSE INFORMED THE STAFF AND MAGNET SWEEPER WAS BROUGHT TO ROOM. REMAINING PIECE OF SUTURE WAS FOUND. BOTH PIECES OF NEEDLE WERE PLACED IN SPECIMEN CUP WITH SUTURE LABEL. THE SURGEON COMPARED BOTH BROKEN PIECES TO A SUTURE OF SAME SIZE AND DIAMETER AND DETERMINED THAT THEY MATCHED. ALL OPERATING AND ANESTHESIA STAFF AGREED THAT ALL PIECES OF SUTURE NEEDLE WERE OBTAINED. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104119 ↗
• InjuryOct 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC GASTRECTOMY, AS SUTURE WAS BEING PULLED OUT OF THE TROCAR NEEDLE POPPED OFF. ALSO, A THREAD BROKE AWAY FROM NEEDLE AT SWAGE WITHOUT ANY TENSION AND FELL OFF INTO THE PATIENT'S CAVITY. IT WAS THEN LOCATED AND RETRIEVED BY USING AN X-RAY DATED (B)(6) 2021. THE SURGICAL TIME WAS EXTENDED FOR 2 HOURS AS A RESULT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 12674674 ↗
• MalfunctionJul 28, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN RADICAL NEPHRECTOMY, DISTAL PANCREATECTOMY, AND SPLEENECTOMY, WHEN THE SURGEON WAS TYING A KNOT, THE SILK SUTURE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236400 ↗
• MalfunctionJul 22, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE MULTIPLE THREADS BROKE. ANOTHER SUTURE FROM A DIFFERENT LOT 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 12214845 ↗

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-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-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-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-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-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
• 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-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-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-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