ETHIBOND EXCEL PX65HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031049246), received between Jan 23, 2018 and Jan 2, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. INTRA OPERATIVELY, THE NEEDLE SHEARED AND BROKE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210321 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. INTRA OPERATIVELY, THE NEEDLE SHEARED AND BROKE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210259 ↗
• InjuryJan 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED IN JOURNAL ARTICLE ¿BARBED VERSUS TRADITIONAL SUTURES: CLOSURE TIME, COST, AND WOUND RELATED OUTCOMES IN TOTAL JOINT ARTHROPLASTY¿ THAT PURPOSE OF THE STUDY WAS TO PROSPECTIVELY INVESTIGATE BARBED SUTURES BY COMPARING THEM TO TRADITIONAL SUTURES. THE PATIENT UNDERWENT TOTAL JOINT ARTHROPLASTY ON UNKNOWN DATE BETWEEN (B)(6) 2010 AND SUTURE WAS USED DISTAL INTERRUPTED AND PROXIMAL RUNNING ON THE FASCIA. POST-OPERATIVELY THE PATIENT MAY HAVE EXPERIENCED PROMINENT SUTURE TREATED WITH REMOVAL WITH FORCEPS AND APPLICATION OF ANTIBIOTIC OINTMENT. THE PATIENT POSSIBLY EXPERIENCED SUPERFICIAL INFECTION SUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS. IN CONCLUSION, BARBED SUTURES ARE ASSOCIATED WITH A DECREASED TIME TO WOUND CLOSURE FOLLOWING TKA'S AND THA'S AND THE FINANCIAL BENEFIT ASSOCIATED WITH SAVING TIME IN THE OPERATING ROOM IS SIGNIFICANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 7213324 ↗

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.