ETHIBOND EXCEL W975GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031238404), received between Jul 23, 2024 and Sep 16, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793834 ↗
• InjuryAug 13, 2025Break; Break

  IT WAS REPORTED THAT A CHILD UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR SURGERY IN A MINIMALLY INVASIVE APPROACH IN A PIRS TECHNIQUE ON (B)(6) 2025 AND SUTURE WAS USED TO CLOSE THE HERNIA SAC. DURING SUTURING, THE NEEDLE BROKE AT THE END OF SUTURING ON THE RIGHT SIDE. WHEN THE NEEDLE ON THE RIGHT SIDE BROKE, THE SURGEON ATTEMPTED TO REMOVE THE FRAGMENT, HOWEVER, DURING THE ATTEMPT, THE NEEDLE FRAGMENT FELL INTO THE PELVIS. THE SURGEON TRIED TO REMOVE THE FRAGMENT FROM THE PELVIS, AND WHEN UNSUCCESSFUL, SHE DECIDED TO CONTINUE AND COMPLETE THE SURGERY. IT WAS DECIDED TO COMPLETE THE HERNIA REPAIR (ON THE RIGHT SIDE) USING A DIFFERENT TYPE OF SUTURE FOR TYING - WITHOUT NEEDLES. AT THE END OF THE SURGERY, AN AP AND LATERAL EMPTY ABDOMEN X-RAY WAS PERFORMED, WHICH, ACCORDING TO THE SURGEON, IDENTIFIED THE BROKEN NEEDLE FRAGMENT. THE BROKEN NEEDLE FRAGMENT ON THE RIGHT SIDE WAS LOCATED IN THE PELVIS. THAT SAME EVENING, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE BROKEN NEEDLE FRAGMENT. THE PROCEDURE ENDED SUCCESSFULLY, AND ACCORDING TO THE SURGEON, THE NEEDLE FRAGMENT WAS REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS DISCHARGED THE NEXT DAY IN A GOOD GENERAL

  Patient problems: Foreign Body In Patient

  MAUDE report 22794760 ↗
• InjuryAug 13, 2025Break; Break

  IT WAS REPORTED THAT A CHILD UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR SURGERY IN A MINIMALLY INVASIVE APPROACH IN A PIRS TECHNIQUE ON (B)(6) 2025 AND SUTURE WAS USED TO CLOSE THE HERNIA SAC. DURING SUTURING, THE NEEDLE BROKE AT THE END OF SUTURING ON THE LEFT SIDE. AFTER THE NEEDLE ON THE LEFT SIDE BROKE, THE SURGEON THOUGHT THAT THE FRAGMENT FROM THIS NEEDLE HAD FALLEN OUT OF THE SURGICAL FIELD AND CONTINUED TO THE RIGHT SIDE. IT WAS DECIDED TO COMPLETE THE HERNIA REPAIR USING A DIFFERENT TYPE OF SUTURE FOR TYING - WITHOUT NEEDLES. AT THE END OF THE SURGERY, AN AP AND LATERAL EMPTY ABDOMEN X-RAY WAS PERFORMED, WHICH, ACCORDING TO THE SURGEON, IDENTIFIED THE BROKEN NEEDLE FRAGMENT. THE BROKEN NEEDLE FRAGMENT ON THE LEFT SIDE WAS LOCATED IN THE ABDOMINAL WALL. THAT SAME EVENING, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE BROKEN NEEDLE FRAGMENT. THE PROCEDURE ENDED SUCCESSFULLY, AND ACCORDING TO THE SURGEON, THE NEEDLE FRAGMENT WAS REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS DISCHARGED THE NEXT DAY IN A GOOD GENERAL CONDITION. ACCORDING TO THE SURGEON, SHE HELD THE NEEDLE IN PROXIMITY TO THE ATTACHMENT POINT BETWEEN THE NEEDLE AND THE SUTURE IN ORDER

  Patient problems: Foreign Body In Patient

  MAUDE report 22794722 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE IS COMING OFF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809319 ↗

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.