ETHICON M655GRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031045491), received between Jul 9, 2018 and Mar 13, 2026 — classified as 2 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (26 reports).

8 other recalls cover devices cleared under the same FDA submission (K170767, 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590221 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKING AT NEEDLE SITE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23869473 ↗
• MalfunctionJul 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THERE WAS BLACK DEBRIS NOTICED OUTSIDE THE RUBBER PROTECTOR OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531634 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE SUDDENLY BROKE WHEN SUTURING THE STERNUM. THE BROKEN NEEDLE AND FRAGMENTS WERE REMOVED IN TIME AND SPLICED TOGETHER COMPLETELY TO CONFIRM THAT THERE WERE NO FALLEN FRAGMENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21172311 ↗
• MalfunctionMay 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND STERNAL WIRE WAS PLACED UPON CLOSING THE STERNOTOMY. INCIDENCE OF THE WIRES BREAKING INSIDE THE PATIENT WAS REPORTED INTRA OPERATIVELY. THE BREAKAGE DID NOT OCCUR WHERE THE SURGEON WAS TYING/TIGHTENING THE WIRES, BUT INSTEAD SNAPPING/BREAKING WHERE THEY WERE PLACED IN TISSUE/BONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398695 ↗
• InjuryMay 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND STERNAL WIRE WAS PLACED UPON CLOSING THE STERNOTOMY. THE PATIENT HAD TO BE BROUGHT BACK POST OP BECAUSE ONE WIRE WAS STICKING THE PATIENT AND CAUSING PAIN. THE BREAKAGE DID NOT OCCUR WHERE THE SURGEON WAS TYING/TIGHTENING THE WIRE, BUT INSTEAD SNAPPING/BREAKING WHERE IT WAS PLACED IN TISSUE/BONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain

  MAUDE report 19398694 ↗
• MalfunctionMay 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON 28-APR-2024 AND STERNAL WIRE WAS PLACED UPON CLOSING THE STERNOTOMY. INCIDENCE OF THE WIRES BREAKING INSIDE THE PATIENT WAS REPORTED INTRA OPERATIVELY. THE BREAKAGE DID NOT OCCUR WHERE THE SURGEON WAS TYING/TIGHTENING THE WIRES, BUT INSTEAD SNAPPING/BREAKING WHERE THEY WERE PLACED IN TISSUE/BONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398693 ↗
• MalfunctionMar 27, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PASSAGE OF THE STEEL WIRE THROUGH THE PATIENT'S STERNUM FOR OSTEOSYNTHESIS, THE TIP OF THE NEEDLE HAD BROKEN OFF AND FALLEN INTO THE PATIENT. THE TIP OF THE NEEDLE WAS FOUND. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986219 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE DOCTOR EXPERIENCED THIS SUTURE CONTINUOUSLY TO BREAK UNINTENTIONALLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443083 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE STERNAL WIRES (ITEM # M655) HAVE BEEN BREAKING WHILE TWISTING AND APPLYING SLIGHT PRESSURE. THE SURGEON AND PA SIMPLY USED OTHER WIRES TO COMPLETE THE STERNAL CLOSURE WITHOUT ANY HARM TO THE PATIENT. NO DELAYS AND NO FRAGMENTS MADE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269851 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE STERNAL WIRES (ITEM # M655) HAVE BEEN BREAKING WHILE TWISTING AND APPLYING SLIGHT PRESSURE. THE SURGEON AND PA SIMPLY USED OTHER WIRES TO COMPLETE THE STERNAL CLOSURE WITHOUT ANY HARM TO THE PATIENT. NO DELAYS AND NO FRAGMENTS MADE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269848 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE STERNAL WIRES (ITEM # M655) HAVE BEEN BREAKING WHILE TWISTING AND APPLYING SLIGHT PRESSURE. THE SURGEON AND PA SIMPLY USED OTHER WIRES TO COMPLETE THE STERNAL CLOSURE WITHOUT ANY HARM TO THE PATIENT. NO DELAYS AND NO FRAGMENTS MADE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269821 ↗
• MalfunctionAug 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT A NEEDLE POPPED OFF OF A STEEL STERNAL WIRE. COORDINATOR STATED THAT NEEDLE AND PACKAGING ARE AVAILABLE FOR RETURN. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477319 ↗
• MalfunctionJul 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. A HAIR WAS FOUND ON A PACKAGE OF 7 STEEL WIRES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379694 ↗
• MalfunctionJul 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. A HAIR WAS FOUND ON A PACKAGE OF 7 STEEL WIRES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378848 ↗
• MalfunctionJun 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR THAT WHEN THEY RECEIVED THE SHIPMENT THE PRODUCTS INSIDE WERE SIGNIFICANTLY DAMAGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107839 ↗
• MalfunctionJun 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR THAT WHEN THEY RECEIVED THE SHIPMENT THE PRODUCTS INSIDE WERE SIGNIFICANTLY DAMAGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107838 ↗
• MalfunctionMar 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON WAS CLOSING THE STERNUM AND ON HIS FIRST PASS WITH THE NEEDLE THRU THE MENUBRIUM, HE PULLED UP ON THE NEEDLE AND THE NEEDLE BROKE. THEY GOT A SECOND STERNAL WIRE, HE TOOK TWO BITES, ONE ON EACH SIDE OF THE MENUBRIUM, PULLED UP ON THE NEEDLE AND THE SECOND NEEDLE BROKE. THEY THEN GOT A THIRD STERNAL WIRE, TOOK TWO PASSES, PULLED UP AND THE NEEDLE POPPED OFF THE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576367 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON WAS CLOSING THE STERNUM AND ON HIS FIRST PASS WITH THE NEEDLE THRU THE MENUBRIUM, HE PULLED UP ON THE NEEDLE AND THE NEEDLE BROKE. THEY GOT A SECOND STERNAL WIRE, HE TOOK TWO BITES, ONE ON EACH SIDE OF THE MENUBRIUM, PULLED UP ON THE NEEDLE AND THE SECOND NEEDLE BROKE. THEY THEN GOT A THIRD STERNAL WIRE, TOOK TWO PASSES, PULLED UP AND THE NEEDLE POPPED OFF THE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576329 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON WAS CLOSING THE STERNUM AND ON HIS FIRST PASS WITH THE NEEDLE THRU THE MENUBRIUM, HE PULLED UP ON THE NEEDLE AND THE NEEDLE BROKE. THEY GOT A SECOND STERNAL WIRE, HE TOOK TWO BITES, ONE ON EACH SIDE OF THE MENUBRIUM, PULLED UP ON THE NEEDLE AND THE SECOND NEEDLE BROKE. THEY THEN GOT A THIRD STERNAL WIRE, TOOK TWO PASSES, PULLED UP AND THE NEEDLE POPPED OFF THE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576263 ↗
• MalfunctionJan 6, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC DISSECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE DEBRIS WAS FOUND, WHICH FELL OFF FROM THE SUTURE DURING THE PROCEDURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114958 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IN THE PROCESS OF USE, IT IS FOUND THAT THE DREGS OF SUTURE PRODUCTS FALL. 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 16067865 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STERNAL WIRE/NEEDLE TIP BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597343 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STERNAL WIRE/NEEDLE TIP BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597342 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STERNAL WIRE/NEEDLE TIP BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170767, 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.