ETHIBOND EXCEL MB47GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031046283), received between Mar 7, 2018 and Feb 2, 2026 — classified as 5 malfunctions.

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

• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE AHS THAT DURING AN UNKNOWN PROCEDURE, THE ATRAUMATIC SUTURE NEEDLE BROKE OFF IN PATIENT, ABOUT 5 MM. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236762 ↗
• MalfunctionAug 14, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP PROCEDURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780489 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED ON USER FACILITY MEDWATCH FORM, # 2300750000-2018-8007. A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018 AND SUTURE WAS USED. A PIECE OF SUTURE NEEDLE BROKE DURING GRAFT STITCHING. PHYSICIAN WAS MADE AWARE IMMEDIATELY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7763898 ↗
• MalfunctionMar 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PETELLAR TENDON RECONSTRUCTION PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF. IT IS UNKNOWN WHERE THE NEEDLE BROKE ON THE SECOND DEVICE. X-RAYS WERE TAKEN TO SEE IF THE TIP COULD BE LOCATED. THERE WAS NO SIGN OF THE NEEDLE INSIDE OF THE PATIENT. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320963 ↗
• MalfunctionMar 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PETELLAR TENDON RECONSTRUCTION PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF. IT IS UNKNOWN WHERE THE NEEDLE BROKE ON THE SECOND DEVICE. X-RAYS WERE TAKEN TO SEE IF THE TIP COULD BE LOCATED. THERE WAS NO SIGN OF THE NEEDLE INSIDE OF THE PATIENT. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320940 ↗

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.