ETHIBOND EXCEL D6165Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031026117), received between Aug 28, 2026 and Aug 28, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Positioning Failure” (4 reports).

8 other recalls cover devices cleared under the same FDA submission (K946173); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Positioning Failure

  It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50497948 ↗
• InjuryAug 28, 2026Positioning Failure

  It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50497931 ↗
• InjuryAug 28, 2026Positioning Failure

  It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50497893 ↗
• InjuryAug 28, 2026Positioning Failure

  It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50497881 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.