ETHILON 699HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031008632), received between May 26, 2021 and Apr 28, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WHEN USING THE SUTURE THREAD, THE NEEDLE BROKE OFF THE THREAD, WHICH REMAINED IN THE PATIENT'S SKIN. WE WOULD LIKE TO PASS THIS ON, YOU MAY HAVE HAD MORE COMPLAINTS ABOUT THIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919385 ↗
• MalfunctionNov 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOW DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD A PROVIDER SUTURING A PATIENT AND ON THE FIRST SET OF SUTURES, THE NEEDLE PULLED OFF OF THE SUTURE THREAD. SHE THOUGHT THAT WAS WEIRD AND PERHAPS SHE PULLED HARD WHEN SECURING, SO SHE GOT A 2ND SUTURE WITH THE SAME LOT AND THE SAME THING HAPPENED. THE NEEDLE DISCONNECTED FROM THE SUTURE THREAD. SHE THEN JUST GOT A DIFFERENT SIZE SUTURE AND OPENED A 3RD PACKAGE WITH THE SAME LOT NUMBER AND WAS ABLE TO EASILY DISCONNECT THE THREAD FROM THE SUTURE NEEDLE JUST BY SLIGHTLY TUGGING ON IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609904 ↗
• MalfunctionNov 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOW DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD A PROVIDER SUTURING A PATIENT AND ON THE FIRST SET OF SUTURES, THE NEEDLE PULLED OFF OF THE SUTURE THREAD. SHE THOUGHT THAT WAS WEIRD AND PERHAPS SHE PULLED HARD WHEN SECURING, SO SHE GOT A 2ND SUTURE WITH THE SAME LOT AND THE SAME THING HAPPENED. THE NEEDLE DISCONNECTED FROM THE SUTURE THREAD. SHE THEN JUST GOT A DIFFERENT SIZE SUTURE AND OPENED A 3RD PACKAGE WITH THE SAME LOT NUMBER AND WAS ABLE TO EASILY DISCONNECT THE THREAD FROM THE SUTURE NEEDLE JUST BY SLIGHTLY TUGGING ON IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609869 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME LOOSE FROM THE THREAD WHILE PULLING IT THROUGH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768763 ↗
• InjuryFeb 28, 2022Positioning Failure; Product Quality Problem; Positioning Failure; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HAND SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE KNOT OPENED. A DEHISCENCE OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13618325 ↗
• InjuryFeb 28, 2022Positioning Failure; Product Quality Problem; Positioning Failure; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HAND SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE KNOT OPENED. A DEHISCENCE OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13618323 ↗
• InjuryFeb 28, 2022Positioning Failure; Product Quality Problem; Positioning Failure; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HAND SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE KNOT OPENED. A DEHISCENCE OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13618320 ↗
• MalfunctionNov 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NECK PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SKIN CLOSURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803742 ↗
• MalfunctionNov 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NECK PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SKIN CLOSURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803716 ↗
• MalfunctionMay 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SKIN CLOSURE, THE SUTURE PULLED OUT FROM THE SWAGED END OF THE NEEDLE ON THE FIRST PASS WITH MINIMAL TENSION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884722 ↗

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-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-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-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.