Sofsilk GS-46-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521085015), received between Mar 27, 2018 and Nov 17, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WAS A DIFFERENTLY PACKAGING QUANTITY. THERE ARE MORE NEEDLES. THERE WERE SIX NEEDLES. ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158032 ↗
• MalfunctionMay 5, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE PACKAGING WAS LABELED 5 UNITS BUT THE NUMBER OF DEVICES FOUND WERE SIX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882725 ↗
• MalfunctionApr 9, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING THE PREPARATION OF THE OPERATION, THE SCRUB NURSE OPENED THE PACKAGE OF THE SUTURE AND FOUND THAT THERE WERE 6 STRANDS OF THE SUTURE IN THE PACKAGE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9943875 ↗
• MalfunctionJun 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN SUTURING THE DURA MATER DURING AN OPEN NEUROSURGERY, THE NEEDLE BROKE WHILE DETACHING FROM THE THREAD. THE 15MM OF THE NEEDLED REMAINED WITH THE THREAD AND 2MM OF THE NEEDLE WAS TORN. THE THREAD WAS CUT MANUALLY TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8661542 ↗
• InjuryApr 18, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER DURING AN EXPLORATORY LAPAROTOMY PROCEDURE, WHILE THE BOWEL WAS BEING SUTURED FOR ANASTOMOSIS, THE NEEDLE BROKE AND A PIECE COULD NOT BE FOUND. TWO NEEDLE BROKE, BOTH FROM THE SAME BOX BUT NOT THE SAME PACK. ALL PIECES WERE LOCATED TO ONE NEEDLE. THE OTHER STILL HAD A MISSING PIECE. MORE SUTURE WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. AN X- RAY WAS USED HOWEVER THEY NEEDED TO USE IT AS PART OF THE PROCEDURE NOT JUST TO LOOK FOR THE NEEDLE. THE NEEDLE WAS NOT LOCATED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 7441434 ↗
• MalfunctionMar 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY ILEO ANASTOMOSIS, WHILE THE DOCTOR WAS PERFORMING A SURGEON¿S KNOT, THE NEEDLE WAS PUSHED THROUGH THE TISSUE AND THEN GRASPED AND WHEN IT WAS GRASPED THE TIP OF THE NEEDLE BROKE OFF IN THE JAWS OF THE INSTRUMENT. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE AND A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374554 ↗

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-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-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-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-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-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-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-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