Sofsilk S-187Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521085985), received between Jan 18, 2023 and Jan 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

11 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 21, 2023Open, Classified

   Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

   Z-0845-2024 · Root cause: Process control · FDA record ↗

2. Dec 2, 2022Open, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1176-2023 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2023Component Missing; Insufficient Device Problem Information; Component Missing; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE FIRST FOUR SUTURES HAD NO NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 16194614 ↗

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-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-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-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-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-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-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-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-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