ETHICON 635HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031007161), received between Feb 6, 2018 and Jun 11, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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.

• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BREAKS AND THEN CURLS DURING USE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508472 ↗
• MalfunctionJun 30, 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 BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880833 ↗
• MalfunctionMay 19, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE IS FRAYING AT THE ENDS ONCE IT IS CUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438336 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SURGEON USED IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10520958 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SURGEON USED IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10520943 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SURGEON USED IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10520935 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SURGEON USED IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10520933 ↗
• MalfunctionNov 15, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE UNDER NORMAL CONDITIONS. WHEN A DOCTOR WAS PULLING ON IT, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9329952 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL SURGERY PROCEDURE IN (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYING AND BROKE APART. ADDITIONAL SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736111 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL EXTRACTION PROCEDURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF OF THE SUTURE WHILE IT WAS BEING PULLED THROUGH TISSUE. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450773 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL EXTRACTION PROCEDURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF OF THE SUTURE WHILE IT WAS BEING PULLED THROUGH TISSUE. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450767 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL EXTRACTION PROCEDURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF OF THE SUTURE WHILE IT WAS BEING PULLED THROUGH TISSUE. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450757 ↗
• InjuryFeb 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT FOOT PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. POST OPERATIVELY, WITHIN 5 DAYS, THE PATIENT EXPERIENCED ALLERGIC REACTION, PAIN, BURNING SENSATION AND BLEEDING FROM THE SITE. THE PATIENT REPORTED SHE WAS TREATED WITH ANTIBIOTICS AND PRESCRIPTION STEROID AND OTHER UNSPECIFIED ALLERGY MEDICATION. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Blood Loss; Burning Sensation; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 7244847 ↗

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.