Sofsilk GSJ-34-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521085312), received between Aug 23, 2018 and Feb 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  ACCORDING TO THE REPORTER, IN A COLECTOMY, IT WAS NOTED THAT THE NEEDLE TIP WAS BROKEN WHEN THE SURGEON HANDED THE FORCEPS, STILL CLAMPING THE NEEDLE TIP, TO THE SCRUB NURSE AFTER SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311032 ↗
• MalfunctionSep 28, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE WHICH SUPPOSEDLY INCLUDES FIVE PIECES, SIX PIECES WERE FOUND INSTEAD. THE SURGEON DID NOT USED THE DEVICE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496880 ↗
• MalfunctionJul 14, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SUTURE PACK WAS OPENED, ONE NEEDLE WAS LACKING. A NEW PACKET WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170529 ↗
• MalfunctionMar 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, ONLY FOUR NEEDLE SUTURES WERE IN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444840 ↗
• MalfunctionDec 7, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL GASTRECTOMY, AFTER USING ONE SUTURE, THE PHYSICIAN WAS TOLD THAT SIX SUTURES REMAINED BY THE NURSE. SINCE THE PRODUCT SHOULD INCLUDE 5 SUTURES, A NEW PRODUCT WAS USED DUE TO DISTRUST. ONE SUTURE WHICH WAS USED WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960621 ↗
• MalfunctionDec 17, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE SIX PRODUCTS INSIDE ONE PACKET, SO IT CAUSED TROUBLE IN COUNTING THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9485315 ↗
• MalfunctionSep 26, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, AFTER CLOSURE OF INCISION AT PROXIMAL PANCREATICODUODENECTOMY, THE NEEDLES AND PACKETS WERE CHECKED, AND THERE MIGHT HAVE BEEN 6 SUTURES IN A 5 PRODUCTS PACKAGE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9125407 ↗
• MalfunctionApr 17, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, 6 NEEDLES ATTACHING WITH THREADS WERE FOUND TO BE CONTAINED IN ONE PACK WHICH SHOULD CONTAIN 5 NEEDLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Information

  MAUDE report 8524102 ↗
• MalfunctionAug 23, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NURSE FOUND THE TIP OF THE NEEDLE CRUSHED. THIS DEVICE WAS NOT USED. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7811257 ↗

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-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-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-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-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-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
• 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-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-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