ETHIBOND EXCEL X425HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031057296), received between Dec 5, 2017 and Apr 8, 2026 — classified as 1 injury, 11 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Discolored

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THERE WAS BLACK DISCOLORATION NOTED INSIDE OF PACKAGE. WAS NOT USED FOR SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816170 ↗
• MalfunctionFeb 4, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BLACK DISCOLORATION NOTED INSIDE OF PACKAGE. WAS NOT USED FOR SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261231 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT WHILE SUTURING THE RIGHT HIP. X-RAY WAS TAKEN AND NO REMNANT APPEARED TO BE PRESENT IN THE PATIENT. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT, BUT SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774432 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS REPORTED AS BEING WEAK. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288508 ↗
• InjuryNov 2, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS ALSO REPORTED THAT THE DOCTOR SAW THE PATIENT SITTING IN THE LOTUS YOGA POSITION WHEN SHE DID HER ROUNDS ON THE 7TH OR 8TH OF (B)(6). THE PATIENT WAS TOLD DO NOT TO SIT LIKE THAT, BECAUSE IT PUTS TENSION ON THE WOUND. IN ADDITION, THE DOCTOR NOTICED THAT THE PATIENT WAS ALSO JUMPING IN AND OUT OF THE HOSPITAL BED, BEING OVERLY BUSY, AND NOT RESTING. AS PER DOCTOR, THE PATIENT IS BIPOLAR. THE NEXT DAY, THE PATIENT AGAIN WAS SITTING IN THE LOTUS POSITION. THIS TIME THE PATIENT WAS NOT TOLD TO REFRAIN FROM SITTING IN THE LOTUS POSITION. THE DOCTOR OPINED THAT SHE COULD NOT UNDERSTAND WHY THE PATIENT WOULD SIT THAT WAY AFTER A SURGICAL PROCEDURE, AND HOW IT COULD NOT BE PAINFUL OR UNCOMFORTABLE. THE PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2021 AS WOUND WAS OPEN. THE ANESTHETIST INSISTED ON 6 HOURS WAIT BEFORE GOING TO OPERATING ROOM BECAUSE THE PATIENT HAD A MEAL. UPON OPENING THE PATIENT TO ASSESS IF THERE WAS DAMAGED AND TO CLOSE THE WOUND, THE KNOTS WERE INTACT BUT THE SUTURE WAS FOUND CUT/BROKEN IN HALF. THE WOUND WAS RE-CLOSED AND THE PATIENT SEEMS FIN

  Patient problems: Wound Dehiscence

  MAUDE report 12741713 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. BOTH FRAGMENTS WERE RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672661 ↗
• MalfunctionJan 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF WHILE THE SURGEON WAS CLOSING FASCIA. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641167 ↗
• MalfunctionJan 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF WHILE THE SURGEON WAS CLOSING FASCIA. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641164 ↗
• MalfunctionJan 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF WHILE THE SURGEON WAS CLOSING FASCIA. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641163 ↗
• MalfunctionJan 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF WHILE THE SURGEON WAS CLOSING FASCIA. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641162 ↗
• MalfunctionDec 5, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE PACKAGE HAD BEEN DAMAGED AND HAD A HOLE BEFORE OPENING THE PACKAGE. THE PACKAGE HAD BEEN STORED FOR A LONG TIME. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7082642 ↗
• MalfunctionDec 5, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE PACKAGE HAD BEEN DAMAGED AND HAD A HOLE BEFORE OPENING THE PACKAGE. THE PACKAGE HAD BEEN STORED FOR A LONG TIME. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7082639 ↗

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-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.