Sofsilk GS-33-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521084858), received between Mar 6, 2018 and Aug 21, 2025 — classified as 1 injury, 3 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 18, 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.

• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING.

  Patient problems: Insufficient Information

  MAUDE report 22858617 ↗
• InjuryJan 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE USING THE SUTURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY. IMAGING WAS REQUIRED TO LOCATE THE NEEDLE. A NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21126741 ↗
• MalfunctionFeb 18, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE BROKE. COMPONENT FELL INTO CAVITY BUT THE NEEDLE WAS SAFELY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348692 ↗
• MalfunctionMar 6, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WERE 2 OF OUT THE 5 NEEDLES THAT BROKE AT THE TIP. THE TIP OF THE NEEDLE DISENGAGED INTO THE PATIENT AND IT WAS RETRIEVED BY THE PHYSICIAN WITH GRASPERS. TO COMPLETE THE PROCEDURE, A NEW DEVICE WAS USED. THERE WAS NO HARM CAUSED TO THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316213 ↗

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-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-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-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-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
• 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-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-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-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