Sofsilk CS-10-MRecalls & reported problems

Covidien LP · Wax Coated Braided Silk · Class 2 · Implant

All models of Sofsilk (120)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

These Covidien Sofsilk silk sutures are nonabsorbable, wax-coated braided silk stitches. The 26 reports mostly describe the thread breaking during procedures, sometimes requiring another device; one report mentions an incorrect needle count. The reports mention no deaths or injuries, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 26
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521083578), received between Jun 15, 2023 and Mar 25, 2025 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (24 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break24
Manufacturing, Packaging or Shipping Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions25
Insufficient Information1

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT HAS SIX NEEDLES INSTEAD OF FIVE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689196 ↗
MalfunctionNov 21, 2023Break; Break
ACCORDING TO THE REPORTER, THE THREAD BROKE.
Patient problems: Insufficient Information
MAUDE report 18188187 ↗
MalfunctionNov 9, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108020 ↗
MalfunctionNov 9, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108014 ↗
MalfunctionNov 9, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108000 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095750 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095691 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095687 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095685 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095391 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095370 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095348 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095317 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095276 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093794 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093762 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093728 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093671 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093636 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093534 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093430 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093381 ↗
MalfunctionNov 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093311 ↗
MalfunctionNov 7, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18086332 ↗
MalfunctionNov 7, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWENTY THREE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18084323 ↗

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-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-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-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-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-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-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-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

Device details

UDI-DI	`10884521083578`
Brand	Sofsilk
Model	CS-10-M
Company	Covidien LP
Product code	GAP · SUTURE, NONABSORBABLE, SILK
Class	Class 2
FDA submission	K981128
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Silk suture

A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Other SUTURE, NONABSORBABLE, SILK devices

Sofsilk S-2782K
Covidien LP · SUTURE, NONABSORBABLE, SILK
3 recalls0 reports
PERMA-HAND SA86G
Ethicon, LLC · SUTURE, NONABSORBABLE, SILK
120 reports
Sofsilk S-1768K
Covidien LP · SUTURE, NONABSORBABLE, SILK
2 recalls5 reports
Sofsilk S-316
Covidien LP · SUTURE, NONABSORBABLE, SILK
2 recalls2 reports
Sofsilk S-304
Covidien LP · SUTURE, NONABSORBABLE, SILK
2 recalls2 reports
Sofsilk S-187
Covidien LP · SUTURE, NONABSORBABLE, SILK
2 recalls1 report
Sofsilk S-605
Covidien LP · SUTURE, NONABSORBABLE, SILK
2 recalls1 report
Sofsilk S-176
Covidien LP · SUTURE, NONABSORBABLE, SILK
2 recalls0 reports

All SUTURE, NONABSORBABLE, SILK devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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