ETHIBOND EXCEL X558HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031057579), received between May 9, 2018 and Apr 17, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NURSE OPENED THE PRODUCT PACKAGING, AS SOON AS THE SUTURE WAS USED, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. NEW SUTURE HAS BEEN REPLACED, AND THE DEFECTIVE SUTURE WAS DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913278 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON THE HAND ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT HAD EXPERIENCED A RUPTURE OF THE EXTENSOR TENDON IN THE SECOND AND FOURTH FINGERS OF THE LEFT HAND. DURING THE PROCEDURE, THE DOCTOR USED SUTURE TO SUTURE THE TENDON. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING. ON THE AFTERNOON OF THE THIRD DAY AFTER SURGERY, THE PATIENT MOVED THE ELBOW JOINT ON THEIR OWN AND FELT THAT THE TENDON HAD RUPTURED AGAIN. AFTER PHYSICAL EXAMINATION, IT WAS CONSIDERED THAT THE EXTENSOR TENDON HAD RUPTURED AGAIN. ON THE FOURTH DAY AFTER SURGERY, THE PATIENT UNDERWENT ANOTHER SURGERY TO SUTURE THE RUPTURED TENDON. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Muscle/Tendon Damage

  MAUDE report 23788017 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, WHEN THE SUTURE IS PASSED THROUGH AND IS ABOUT TO BE PULLED UP, THE SUTURE BROKE IN THE MIDDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292682 ↗
• MalfunctionApr 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128628 ↗
• MalfunctionJun 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS POPPING OFF OF THE NEEDLE AT THE SWAGE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737463 ↗
• MalfunctionNov 5, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CUSTOMER OPENED A BOX OF SUTURE ON AN UNKNOWN DATE AND FOUND THE SUTURE PACKET SEEMED TO BE CONTAMINATED. IT WAS STAINED YELLOW ON ONE END, AND THE YELLOW HAD SEEPED INTO THE PACKET AND WAS ALSO STAINING THE PLASTIC SUTURE HOLDER. THE YELLOWED PACKET WAS INTERSPERSED BETWEEN NORMAL PACKETS WITHIN THE BOX. IT WAS REPORTED THAT THE PACKET SMELLED FUNNY. THE BOX LOOKED NORMAL, NO EVIDENCE OF STAINING, AND THE OUTER CLEAR PLASTIC SEAL WAS NOT COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038579 ↗
• MalfunctionNov 5, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CUSTOMER OPENED A BOX OF SUTURE ON AN UNKNOWN DATE AND FOUND THE SUTURE PACKET SEEMED TO BE CONTAMINATED. IT WAS STAINED YELLOW ON ONE END, AND THE YELLOW HAD SEEPED INTO THE PACKET AND WAS ALSO STAINING THE PLASTIC SUTURE HOLDER. THE YELLOWED PACKET WAS INTERSPERSED BETWEEN NORMAL PACKETS WITHIN THE BOX. IT WAS REPORTED THAT THE PACKET SMELLED FUNNY. THE BOX LOOKED NORMAL, NO EVIDENCE OF STAINING, AND THE OUTER CLEAR PLASTIC SEAL WAS NOT COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038578 ↗
• MalfunctionNov 5, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CUSTOMER OPENED A BOX OF SUTURE ON AN UNKNOWN DATE AND FOUND THE SUTURE PACKET SEEMED TO BE CONTAMINATED. IT WAS STAINED YELLOW ON ONE END, AND THE YELLOW HAD SEEPED INTO THE PACKET AND WAS ALSO STAINING THE PLASTIC SUTURE HOLDER. THE YELLOWED PACKET WAS INTERSPERSED BETWEEN NORMAL PACKETS WITHIN THE BOX. IT WAS REPORTED THAT THE PACKET SMELLED FUNNY. THE BOX LOOKED NORMAL, NO EVIDENCE OF STAINING, AND THE OUTER CLEAR PLASTIC SEAL WAS NOT COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038572 ↗
• MalfunctionNov 5, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CUSTOMER OPENED A BOX OF SUTURE ON AN UNKNOWN DATE AND FOUND THE SUTURE PACKET SEEMED TO BE CONTAMINATED. IT WAS STAINED YELLOW ON ONE END, AND THE YELLOW HAD SEEPED INTO THE PACKET AND WAS ALSO STAINING THE PLASTIC SUTURE HOLDER. THE YELLOWED PACKET WAS INTERSPERSED BETWEEN NORMAL PACKETS WITHIN THE BOX. IT WAS REPORTED THAT THE PACKET SMELLED FUNNY. THE BOX LOOKED NORMAL, NO EVIDENCE OF STAINING, AND THE OUTER CLEAR PLASTIC SEAL WAS NOT COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038569 ↗
• MalfunctionNov 5, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CUSTOMER OPENED A BOX OF SUTURE ON AN UNKNOWN DATE AND FOUND THE SUTURE PACKET SEEMED TO BE CONTAMINATED. IT WAS STAINED YELLOW ON ONE END, AND THE YELLOW HAD SEEPED INTO THE PACKET AND WAS ALSO STAINING THE PLASTIC SUTURE HOLDER. THE YELLOWED PACKET WAS INTERSPERSED BETWEEN NORMAL PACKETS WITHIN THE BOX. IT WAS REPORTED THAT THE PACKET SMELLED FUNNY. THE BOX LOOKED NORMAL, NO EVIDENCE OF STAINING, AND THE OUTER CLEAR PLASTIC SEAL WAS NOT COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038568 ↗
• MalfunctionMay 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE AND SUTURE WAS USED. WHILE ATTEMPTING TO OPEN A SUTURE PACK INTO STERILE FIELD, NURSE FELT INNER SUTURE RETENTION PLASTIC CRUMBLE WITHIN HER FINGERS. SUTURE NOT INTRODUCED INTO FIELD, ANOTHER PULLED. HOSPITAL LOGISTICS NOTIFIED AND BEGAN CHECKING PLASTIC TRAY FOR ALL SUTURE PACKS. PULLED OFF THE SHELF ALL PACKAGES WHERE TRAY CRUMBLED TO THE TOUCH, SOME PACKAGES HAD TEARS IN THE STERILE TYVEK WARRANTING THE SUTURE NON-STERILE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500814 ↗

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.