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GAPClass 2

Suture, Nonabsorbable, Silk

FDA adverse event reports and recall history for suture, nonabsorbable, silk (product code GAP), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
3,959
Deaths
8
Injuries
772
Malfunctions
3,170

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2024-04-29Open, ClassifiedProcess control

    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 and/or ligation.

    One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.

  • 2024-01-29Open, ClassifiedProcess control

    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 X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12

    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.

  • 2023-02-25Open, ClassifiedPackaging process control

    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 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S1768K S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S182 S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36 S183 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S184 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S185 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S187 S-206 SOFSILK* 2 BLK 100CM STDLTH X36 S206 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S243 S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36 S244 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S245 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S246 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S2782K S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S303 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S304 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S305 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S316 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S317 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S318 S-346 SOFSILK* 0 BLK 12X60CM PCT X24 S346 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S605 S-607 SOFSILK* 1 BLK 2X150CM PCT X36 S607 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 S608 SS-523 SOFSILK* 2-0 BLK 75CM SC1 X36 SS523 SS-525 SOFSILK* 1 BLK 75CM SC1 X36 SS525 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS5641 SS-5641G SOFSILK* 4-0 BLK 45CM P13 X12 SS5641G SS-5678 SOFSILK* 5-0 BLK 45CM P11 X36 SS5678 SS-5684 SOFSILK* 3-0 BLK 45CM P14 X36 SS5684 SS-623 SOFSILK* 2-0 BLK 75CM SC2 X36 SS623 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS645 SS-653 SOFSILK* 4-0 BLK 75CM C13 X36 SS653 SS-673 SOFSILK* 5-0 BLK 75CM C12 X36 SS673 SS-683G SOFSILK* 4-0 BLK 45CM C13 X12 SS683G SS-685G SOFSILK* 2-0 BLK 45CM C15 X12 SS685G SS-686 SOFSILK* 4-0 BLK 45CM C12 X12 SS686 SS-689 SOFSILK* 1 BLK 75CM C16 X36 SS689 SS-745 SOFSILK* 3-0 BLK 75CM C12 X36 SS745 SS-786 SOFSILK* 0 BLK 75CM C14 X36 SS786 SS-787 SOFSILK* 1 BLK 75CM C14 X36 SS787 VS-533 SOFSILK* 2-0 BLK 90CM V20 DAX36 VS533 VS-845 SOFSILK* 1 BLK 75CM V26 X36 VS845 VS-870 SOFSILK* 5-0 BLK 75CM CV23 X36 VS870 VS-871 SOFSILK* 4-0 BLK 75CM CV23 X36 VS871 SOFSILK 4-0 30 BK CV-23 VS871-2 VS8712 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872 SOFSILK 3-0 30 BK CV-23 VS872-2 VS8722 VS-882 SOFSILK* 3-0 BLK 75CM CV15 X36 VS882 SOFSILK 5-0 30 BK CV-11 VS890-2 VS8902 XX-5278 SOFSILK* 3-0 BLK 150CM PCT X36 XX5278 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 XX5280 XX-5281 SOFSILK* 1 BLK 150CM PCT X36 XX5281 XX-5284 SOFSILK* 4 BLK 150CM PCT X36 XX5284

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

  • 2015-01-09TerminatedOther

    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

    Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

  • 2014-05-07TerminatedEmployee error

    Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.

    Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

  • 2011-07-15TerminatedEquipment maintenance

    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 in the cardiovascular, ophthalmic, microsurgery and neurological surgery

    Potential for the sterile barrier to be breached compromising the sterility of the product

  • 2011-07-15TerminatedEquipment maintenance

    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 cardiovascular, ophthalmic, microsurgery and neurological surgery

    Potential for the sterile barrier to be breached compromising the sterility of the product

  • 2011-07-15TerminatedEquipment maintenance

    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 in the cardiovascular, ophthalmic, microsurgery and neurological surgery

    Potential for the sterile barrier to be breached compromising the sterility of the product

  • 2011-07-15TerminatedEquipment maintenance

    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 cardiovascular, ophthalmic, microsurgery and neurological surgery

    Potential for the sterile barrier to be breached compromising the sterility of the product

  • 2011-07-15TerminatedEquipment maintenance

    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 cardiovascular, ophthalmic, microsurgery and neurological surgery

    Potential for the sterile barrier to be breached compromising the sterility of the product

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