Sofsilk GS-67-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521085121), received between Aug 24, 2017 and May 4, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EXPLORATORY LAPAROTOMY, WHILE AT BOWEL RESECTION, THE NEEDLE OF THE TWO PRODUCTS BROKE AT THE TIP. THE SURGEON WAS GRABBING THE VERY TIP WHEN PERFORMING THE POP OFF WHILE SUTURING THE BOWEL. THE SURGEON DID NOT CONTINUE THE PROCEDURE USING THE SAME PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272809 ↗
• InjuryApr 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SEGMENTECTOMY, WHILE SUTURING, TWO DIFFERENT NEEDLES BROKE INTO TWO PARTS. IT WAS STATED THAT ONE WAS FOUND AND THE OTHER ONE WAS NOT. THE PATIENT WENT THROUGH X-RAY HOWEVER, THE MISSING PIECE WAS NOT FOUND. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE AS THE SURGEON WAS TRYING TO LOCATE THE MISSING BROKEN PART OF THE NEEDLE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8540843 ↗
• MalfunctionAug 24, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING TRAUMA SURGERY, THE DEVICE HAS INCORRECT COUNT ON THE BOX. THERE WERE 6 NEEDLES PRESENT IN THE BOX INSTEAD OF 5 NEEDLES ONLY. IT WAS PASSED ON THE STERILE FIELD BUT NOT USED. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818694 ↗

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-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-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-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-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-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-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-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