Sofsilk GS-63-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521085077), received between Jul 24, 2017 and Dec 12, 2023 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, IT WAS FOUND THAT THE SUTURE MULTIPACK HAD 6 SUTURES INSTEAD OF 5. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315285 ↗
• MalfunctionJan 20, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, ONE THIRD OF NEEDLE BROKE AND IT FELL INTO THE CAVITY OF THE PATIENT. SCRUB NURSE FOUND IT AND GOT OUT OF CAVITY OF THE PATIENT. SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11203015 ↗
• MalfunctionJan 20, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, ONE THIRD OF NEEDLE BROKE AND IT FELL INTO THE CAVITY OF THE PATIENT. THE NURSE FOUND THE NEEDLE AND GOT IT OUT FROM PATIENT CAVITY. THE PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES DUE TO THE DEVICE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202444 ↗
• MalfunctionSep 9, 2020Break; Break

  ACCORDING TO THE REPORTER, THE SURGICAL NEEDLE WAS BROKEN.

  Patient problems: No Information

  MAUDE report 10508127 ↗
• MalfunctionMar 2, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE NURSE WAS PREPARING FOR THE OPERATION, IT WAS FOUND OUT THAT THERE WAS MORE SUTURE CONTAINED IN THE PACKAGE WHEN IT WAS OPENED. THE ORIGINAL NUMBERS OF THE SUTURE THAT MUST BE CONTAINED IN THE PACKAGE ARE FIVE, BUT IN THE PACKAGE THERE WERE SIX. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774402 ↗
• InjuryFeb 19, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HYSTERECTOMY PROCEDURE, WHILE SUTURING A PORTION OF THE BOWEL, THE NEEDLE TIP BROKE AND FELL INTO THE PATIENT'S CAVITY. THIS OCCURRED ON TWO UNITS. AN X-RAY WAS PERFORMED TO LOCATED THE NEEDLE TIP. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended

  MAUDE report 9727335 ↗
• InjuryDec 2, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE WAS BROKEN AND FELL INTO PATIENT'S CAVITY. THE TIP OF THE NEEDLE WAS LEFT IN THE PATIENT AND NOT RETRIEVED.

  Patient problems: No Code Available

  MAUDE report 9394721 ↗
• MalfunctionSep 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC BOWEL RESECTION, THE SURGICAL TECHNICIAN WAS TRYING TO PULL THE SUTURE FROM THE PACKAGE ON THE STERILE FIELD WHEN THE NEEDLES CONSISTENTLY POPPED OFF. THE SUTURE WAS NEVER REMOVED. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7869984 ↗
• MalfunctionOct 23, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTED. THERE WERE 6 NEEDLES IN 1 PACK. (IT MUST BE 5 NEEDLE PER 1 PACK).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6969887 ↗
• InjuryAug 29, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING A LAPAROSCOPIC ASSISTED COLECTOMY PROCEDURE, WHILE ANASTOMOSING THE COLON, THE DEVICE¿S NEEDLE TIP BROKE OFF AND WAS NEVER FOUND/LOCATED AND X-RAY WAS NOT DONE. NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6826463 ↗
• MalfunctionJul 24, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC PROCEDURE. THE DEVICE PACKAGE HAD SIX NEEDLES AND SUTURES BUT IT SHOULD ONLY HAVE FIVE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6736127 ↗

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-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-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-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-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-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-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