ETHIBOND EXCEL X519HRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031057418), received between Apr 20, 2020 and Aug 5, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147017 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147016 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146979 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146947 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. A TOTAL OF 3 PRODUCTS EXPERIENCED THE SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035198 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. A TOTAL OF 3 PRODUCTS EXPERIENCED THE SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035126 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. A TOTAL OF 3 PRODUCTS EXPERIENCED THE SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035114 ↗
• MalfunctionDec 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771618 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT UNDERWENT ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY DUE TO "ROTATOR CUFF INJURY". DURING THE SURGERY, THREE CONSECUTIVE SUTURE BREAKAGES OCCURRED WHILE USING SUTURES. THREE SUTURES WERE REPLACED. THE DOCTOR FINALLY CONFIRMED THAT THE SUTURE WAS FIRMLY SUTURED, AND THE SURGERY WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771304 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT UNDERWENT ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY DUE TO "ROTATOR CUFF INJURY". DURING THE SURGERY, THREE CONSECUTIVE SUTURE BREAKAGES OCCURRED WHILE USING SUTURES. THREE SUTURES WERE REPLACED. THE DOCTOR FINALLY CONFIRMED THAT THE SUTURE WAS FIRMLY SUTURED, AND THE SURGERY WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771275 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT UNDERWENT ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY DUE TO "ROTATOR CUFF INJURY". DURING THE SURGERY, THREE CONSECUTIVE SUTURE BREAKAGES OCCURRED WHILE USING SUTURES. THREE SUTURES WERE REPLACED. THE DOCTOR FINALLY CONFIRMED THAT THE SUTURE WAS FIRMLY SUTURED, AND THE SURGERY WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771195 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE WAS USED TO CLOSE THE WOUND FOR WOUND HEALING. THE SUTURE SUDDENLY BROKE WHILE TYING THE KNOT. THE SURGEON REPLACED WITH ANOTHER SUTURE TO CONTINUE SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760655 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SURGERY, WHEN THE DOCTOR SUTURES THE PATIENT, THE SUTURE IS PRONE TO BREAKAGE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672450 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CONSISTENTLY CUT OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534184 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CONSISTENTLY CUT OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533811 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CONSISTENTLY CUT OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533647 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CONSISTENTLY CUT OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533389 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CONSISTENTLY CUT OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532567 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SUTURE SITE INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15217237 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. TWO WEEKS AFTER THE OPERATION, INCISION INFECTION OCCURRED, AND NO BACTERIAL GROWTH WAS OBSERVED AFTER MULTIPLE WOUND SECRETION CULTURES. ON (B)(6) 2021, THE LESION WAS REMOVED SURGICALLY AND VACUUM SEALING DRAINAGE WAS USED TO PROTECT THE WOUND. DURING THE OPERATION, MORE PURULENT INFLAMMATORY TISSUE WAS FOUND AROUND THE SUTURE AND THE SUTURE WAS THOROUGHLY REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fluid Discharge; Inflammation; Post Operative Wound Infection

  MAUDE report 12347580 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES WERE BROKEN DURING TYING. THERE WAS NO DELAY IN SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368687 ↗
• MalfunctionJan 29, 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 SUTURES WERE BROKEN DURING TYING. THERE WAS NO DELAY IN SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255108 ↗
• MalfunctionApr 20, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACHILLORRHAPHY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978458 ↗

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.