ETHIBOND EXCEL MB66GRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031046290), received between May 22, 2019 and Jun 26, 2026 — classified as 5 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE TIP BROKE OFF FROM AN ETHICON SUTURE DURING A TOTAL KNEE ARTHROPLASTY. A NEEDLE TIP BROKE OFF FROM AN ETHICON SUTURE DURING A TOTAL KNEE ARTHROPLASTY WITH DOCTOR. THE SURGEON WAS CLOSING THE FASCIAL LAYER, WHEN IT WAS DISCOVERED THAT THE DISTAL TIP OF HIS SUTURE WAS MISSING. ONCE THAT WAS DISCOVERED, THE SURGEON ASKED FOR AN X-RAY TO BE TAKEN TO SEE IF THE TIP HAD FALLEN INTO THE PATIENT. THE X-RAY DID NOT SHOW A NEEDLE FRAGMENT PRESENT. SO, THE PATIENT WAS CLOSED UP AND THERE WERE NO FURTHER ISSUES. THE DELAY AMOUNTED TO 1-2 MINUTES DUE TO NEEDING TO TAKE AN EXTRA X-RAY IMAGE. THERE WAS NO REPORTED PATIENT HARM. BECAUSE THIS IS ONE OF SEVERAL BROKEN NEEDLE TIPS ON ETHICON SUTURE AT THIS FACILITY WITHIN THE LAST COUPLE OF MONTHS, SOME OF THE STAFF TESTED THEIR THEORY THAT PERHAPS THE NEEDLE TIP WAS BEING GRASPED AND LOCKED INTO THE NEEDLE HOLDER TOO FAR DISTALLY ON THE NEEDLE. A SUTURE FROM THE SAME LOT WAS TAKEN AND USING THE SAME NEEDLE HOLDERS THAT WERE USED IN THIS CASE, A MEMBER OF THE STAFF GRASPED THE NEEDLE ON THE TIP SIMILAR TO WHERE THE SURGEON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636438 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FRACTURE SURGERY ON (B)(6) 2026 AND SUTURE WAS USED.. THIS CASE IS FROM HEALTH AUTHORITY. DURING SURGICAL SUTURING, THE DOCTOR USED SUTURE TO SUTURE THE PATIENT, BUT THE SUTURE BROKE . THE DOCTOR RE TOOK THE SUTURE AND PERFORMED A SECOND SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792045 ↗
• MalfunctionDec 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, WHEN OPENING THE PACKAGE BEFORE USE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER, WHICH WAS LIKE A NEEDLE TIP OR A METAL PIECE, IN THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905765 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING OPEN BIPOLAR HEMIARTHROPLASTY, WHEN THE DOCTOR TRIED TO SUTURE THE LIGAMENT, NOT SUTURE THE BONES, THE NEEDLE TIP BROKE UNEXPECTEDLY. NO PIECES FELL INTO THE PATIENT. THE ISSUE WAS FOUND IMMEDIATELY, SO THE USE WAS STOPPED. THE HOSPITAL HAS USED THE PRODUCT SO FAR, BUT THIS WAS THE FIRST TIME THAT THE NEEDLE BROKE AS EASILY AS THIS. THE HOSPITAL ALSO SAID THAT PARTICULARLY THE PRODUCT HAS NOT BEEN TOUCHED THE STIFF TISSUES. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849928 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872255 ↗
• MalfunctionAug 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CORE SEPARATED FROM THE CARRIERS, COMPROMISING THE SUTURE INTEGRITY. THIS OCCURRED DURING SURGERY; THREE SUTURES WERE USED AND HAD THE SAME ISSUE. THE SURGERY WAS DELAYED BY 5-7 MINS. THE SURGEON MANAGED TO CLOSE THE TISSUE LAYER SUCCESSFULLY, NO PATIENT IMPACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686855 ↗
• MalfunctionAug 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CORE SEPARATED FROM THE CARRIERS, COMPROMISING THE SUTURE INTEGRITY. THIS OCCURRED DURING SURGERY; THREE SUTURES WERE USED AND HAD THE SAME ISSUE. THE SURGERY WAS DELAYED BY 5-7 MINS. THE SURGEON MANAGED TO CLOSE THE TISSUE LAYER SUCCESSFULLY, NO PATIENT IMPACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686853 ↗
• MalfunctionAug 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CORE SEPARATED FROM THE CARRIERS, COMPROMISING THE SUTURE INTEGRITY. THIS OCCURRED DURING SURGERY; THREE SUTURES WERE USED AND HAD THE SAME ISSUE. THE SURGERY WAS DELAYED BY 5-7 MINS. THE SURGEON MANAGED TO CLOSE THE TISSUE LAYER SUCCESSFULLY, NO PATIENT IMPACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686851 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE REP WHO WAS IN THE CASE THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE THAT THE NEEDLE AND THE SUTURE BROKE. THE FRAGMENT OF THE NEEDLE DID NOT BREAK IN THE PATIENT BUT WAS RECOVERED. ANOTHER SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. NO X-RAY WAS NEEDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. PRODUCT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203075 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE, THEY DRILLED INTO THE BONE, WHILE PASSING THE NEEDLE THROUGH THE BONE THE NEEDLE BROKE IN HALF. THE NEEDLE WAS RETRIEVED. AT THE TIME OF THE CALL IT WAS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT HARM WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572381 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT ACL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. SUTURE HAD BROKEN DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585918 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT ACL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. SUTURE HAD BROKEN DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585914 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT ACL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. SUTURE HAD BROKEN DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585912 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT ACL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. SUTURE HAD BROKEN DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585910 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: CLINICAL EFFICACY OF MODIFIED SACRAL FIXATION UNDER LEONARDO DA VINCI ROBOT LAPAROSCOPY FOR PELVIC ORGAN PROLAPSE. THE AIM OF THIS STUDY WAS TO ANALYZE THE CLINICAL EFFICACY OF MODIFIED SACRAL FIXATION UNDER LEONARDO DA VINCI ROBOT LAPAROSCOPY FOR PELVIC ORGAN PROLAPSE (POP). BETWEEN (B)(6)2020 AND (B)(6) 2021, A TOTAL OF (B)(4) PATIENTS WITH PELVIC ORGAN PROLAPSE (POP) WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO GROUP A (LAPAROSCOPIC Y-MESH, (B)(4)), GROUP B (LAPAROSCOPIC SACROVAGINAL FIXATION, (B)(4)), AND GROUP C (DA VINCI ROBOTIC SACRAL FIXATION, (B)(4)). THE SUBJECTS OF THE THREE GROUPS WERE WOMEN. THE AVERAGE AGE, AVERAGE PROLAPSE TIME, AND AVERAGE DELIVERIES WERE (63.16 ± 11.85) YEARS OLD, (4.56 ± 1.28) YEARS, AND (2.56 ± 1.85) TIMES IN GROUP A, RESPECTIVELY, (62.89 ± 10.74) YEARS OLD, (4.39 ± 1.18) YEARS AND (2.46 ± 1.74) TIMES IN GROUP B, AND (62.78 ± 12.06) YEARS OLD, (4.45 ± 1.12) YEARS, (2.39 ± 1.12) TIMES IN GROUP C. T PATIENTS IN GROUP A WERE TREATED WITH LAPAROSCOPIC Y-SHAPED MESH (BRAND: JOHNSON & JOHNSON, PURCHASED IN (B)(6) MEDICAL EQUIPMENT SALES CO., LTD., (B)(6), CHINA); BOTH SIDES WERE INTERRUPTED SUTURED ON THE MAIN SACRAL LIGAMENT COM

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Prolapse; Unspecified Infection

  MAUDE report 20335633 ↗
• MalfunctionSep 10, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER WHEN SEWING IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180978 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE USING IT TO CLOSE THE STERNUM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767338 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHILE SUTURING IN THE HIP CAPSULE, THE NEEDLE BROKE. ALL FRAGMENTS WERE RETRIEVED, AND NO X-RAY WAS NEEDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466823 ↗
• MalfunctionMay 17, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING SURGICAL USE, THE SUTURE BROKE WHEN THE NEEDLE PULLED ON IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346120 ↗
• MalfunctionApr 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS FOUND THAT THERE HAD BEEN FOREIGN HAIR MATTER IN THE NEWLY DISPENSED SUTURE BEFORE THE SURGERY. THE PACKAGE ISN'T OPENED. NO PATIENT CONSEQUENCES WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173030 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE; 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 19148842 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE; 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 19148841 ↗
• MalfunctionApr 11, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS NOTED THAT THE PRIMARY PACKAGE WAS DAMAGED PRIOR TO USE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086141 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE IN HALF DURING THE CLOSING OF THE PROCEDURE. THEY WERE ABLE TO RETRIEVE BOTH PIECES OF THE NEEDLE WITHOUT NEEDING AN X-RAY. PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM WITH A NEW DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651479 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED SLIGHTLY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010539 ↗

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.