ETHIBOND EXCEL X905HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031058279), received between Feb 1, 2021 and Sep 6, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT EACH ENTRY INTO THE TROCAR, THE NEEDLES COME LOOSE FROM THE THREAD AND REMAIN BLOCKED IN THE TROCAR, LEADING TO A RISK OF NEEDLE LOSS AND INVOLUNTARY WOUNDS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690629 ↗
• MalfunctionSep 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT EACH ENTRY INTO THE TROCAR, THE NEEDLES COME LOOSE FROM THE THREAD AND REMAIN BLOCKED IN THE TROCAR, LEADING TO A RISK OF NEEDLE LOSS AND INVOLUNTARY WOUNDS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690621 ↗
• MalfunctionSep 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON 02/08/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF SEVERAL TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME LOT, BUT A NEEDLE WAS LOST. IT WAS NECESSARY TO VERIFY BY X-RAY THE ABSENCE OF THE DEVICE IN INTRA-BDOMINAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690205 ↗
• MalfunctionSep 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF SEVERAL TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME LOT, BUT A NEEDLE WAS LOST. IT WAS NECESSARY TO VERIFY BY X-RAY THE ABSENCE OF THE DEVICE IN INTRA-"ABDOMINAL". NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690204 ↗
• MalfunctionSep 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF SEVERAL TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME LOT, BUT A NEEDLE WAS LOST. IT WAS NECESSARY TO VERIFY BY X-RAY THE ABSENCE OF THE DEVICE IN INTRA-BDOMINAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690201 ↗
• MalfunctionSep 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF SEVERAL TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME LOT, BUT A NEEDLE WAS LOST. IT WAS NECESSARY TO VERIFY BY X-RAY THE ABSENCE OF THE DEVICE IN INTRA-BDOMINAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690200 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AND A PART OF THE NEEDLE WAS LOST BUT IT SEEMS THAT THE NEEDLE WAS LOST OUTSIDE THE PATIENT . THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387978 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS BROKEN WHEN PASSING THROUGH THE SKIN TO MAKE A SKIN PURSE. THERE WERE NO PATIENT CONSEQUENCES. THE NEEDLE TIP FELL TO THE FLOOR. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346983 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS BROKEN DURING THE SECOND PASSAGE THROUGH THE PATIENT'S SKIN TO FIX THE DRAIN. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345990 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345899 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345885 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345851 ↗
• MalfunctionFeb 1, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN ONE OF THE STERILE PACKAGES THERE IS A HAIR INSIDE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262814 ↗

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.