ETHILON 1669HRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031001879), received between May 29, 2018 and Feb 21, 2025 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE SUTURE THREAD KEPT DETACHING FROM THE NEEDLE. BOX WITH SAME LOT OF PRODUCTS REMOVED FROM CIRCULATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435132 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING FROM NURSES/PHYSICIANS THAT THE SUTURES FROM THE TWO LOT'S KEEP BREAKING MID SOW AND CUTTING THROWING THE SKIN WHILE NOT GUIDING THROUGH CORRECTLY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408890 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BREAKS WHEN USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066082 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE MULTIPLE NEEDLES BROKE OFF. ALL WERE RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES. IT IS UNKNOWN HOW THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821501 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. NEEDLE BROKE OFF. ALL WERE RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821500 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORMS MW5117374, MW5117375, MW5117376, MW5117377, PROVIDER WAS SUTURING LESIONS AFTER LESION REMOVAL AND NEEDLE AND/OR SUTURE FELL OFF OR BROKE WHEN TRYING TO SUTURE. THE NEEDLE BROKE AWAY FROM SUTURE IN THREE KITS AND THE SUTURE ITSELF BROKE APART IN ONE KIT. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066447 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORMS MW5117374, MW5117375, MW5117376, MW5117377, PROVIDER WAS SUTURING LESIONS AFTER LESION REMOVAL AND NEEDLE AND/OR SUTURE FELL OFF OR BROKE WHEN TRYING TO SUTURE. THE NEEDLE BROKE AWAY FROM SUTURE IN THREE KITS AND THE SUTURE ITSELF BROKE APART IN ONE KIT. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065587 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORMS MW5117374, MW5117375, MW5117376, MW5117377, PROVIDER WAS SUTURING LESIONS AFTER LESION REMOVAL AND NEEDLE AND/OR SUTURE FELL OFF OR BROKE WHEN TRYING TO SUTURE. THE NEEDLE BROKE AWAY FROM SUTURE IN THREE KITS AND THE SUTURE ITSELF BROKE APART IN ONE KIT. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064759 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORMS MW5117374, MW5117375, MW5117376, MW5117377, PROVIDER WAS SUTURING LESIONS AFTER LESION REMOVAL AND NEEDLE AND/OR SUTURE FELL OFF OR BROKE WHEN TRYING TO SUTURE. THE NEEDLE BROKE AWAY FROM SUTURE IN THREE KITS AND THE SUTURE ITSELF BROKE APART IN ONE KIT. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064401 ↗
• MalfunctionJan 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157876 ↗
• MalfunctionJan 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157786 ↗
• MalfunctionJan 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157772 ↗
• MalfunctionJan 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157770 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC DIAPHRAGMATIC SECALITH PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THIS WAS REPORTED ON TWO SEPARATED OCCASIONS. IT IS UNKNOWN IF THE NEEDLE WAS RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080850 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC DIAPHRAGMATIC SECALITH PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THIS WAS REPORTED ON TWO SEPARATED OCCASIONS. IT IS UNKNOWN IF THE NEEDLE WAS RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080830 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 03/17/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE BROKE ON THE SKIN AND NOT IN PATIENT. THE DEVICE WAS RETRIEVED. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14790585 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT THE NEEDLE TIP BROKE OFF THE NEEDLE ¿ NO ISSUE OPEN NEW PACKAGING SURGEON THOUGHT IT WAS DUE TO THE WAY HE GRABBED IT WITH HIS INSTRUMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14763509 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE TIP OF NEEDLE WAS RECOVERED BUT UNKNOWN AS TO HOW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364726 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909978 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE IN 2020 AND THE SUTURE WAS USED. WHEN TRYING TO USE SUTURE, THE NEEDLE KEPT POPPING OFF THE SUTURE, LIKE FOR A CONTROL RELEASE SUTURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789869 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE IN 2020 AND THE SUTURE WAS USED. WHEN TRYING TO USE SUTURE, THE NEEDLE KEPT POPPING OFF THE SUTURE, LIKE FOR A CONTROL RELEASE SUTURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789862 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE IN 2020 AND THE SUTURE WAS USED. WHEN TRYING TO USE SUTURE, THE NEEDLE KEPT POPPING OFF THE SUTURE, LIKE FOR A CONTROL RELEASE SUTURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789859 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE IN 2020 AND THE SUTURE WAS USED. WHEN TRYING TO USE SUTURE, THE NEEDLE KEPT POPPING OFF THE SUTURE, LIKE FOR A CONTROL RELEASE SUTURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789842 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE IN 2020 AND THE SUTURE WAS USED. WHEN TRYING TO USE SUTURE, THE NEEDLE KEPT POPPING OFF THE SUTURE, LIKE FOR A CONTROL RELEASE SUTURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789836 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARPAL TUNNEL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE AREA AROUND THE INCISION WAS INFECTED AND THE SKIN AROUND THE INCISION WAS RED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 9723200 ↗

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-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.