ETHILON 689GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031008366), received between Apr 25, 2019 and Jan 16, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE UNITS OF THE PRODUCT WITH THE SAME LOT NUMBER STORED IN THE OPERATING ROOM WERE USED. REPEATED INCIDENTS OF NEEDLE AND SUTURE SEPARATION OCCURRED INTRAOPERATIVELY. DUE TO THIS RECURRING ISSUE, THE CUSTOMER REQUESTED A FULL REPLACEMENT OF ALL REMAINING PRODUCTS FROM THE SAME LOT. THERE WERE NO SURGICAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094368 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE UNITS OF THE PRODUCT WITH THE SAME LOT NUMBER STORED IN THE OPERATING ROOM WERE USED. REPEATED INCIDENTS OF NEEDLE AND SUTURE SEPARATION OCCURRED INTRAOPERATIVELY. DUE TO THIS RECURRING ISSUE, THE CUSTOMER REQUESTED A FULL REPLACEMENT OF ALL REMAINING PRODUCTS FROM THE SAME LOT. THERE WERE NO SURGICAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094366 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE UNITS OF THE PRODUCT WITH THE SAME LOT NUMBER STORED IN THE OPERATING ROOM WERE USED. REPEATED INCIDENTS OF NEEDLE AND SUTURE SEPARATION OCCURRED INTRAOPERATIVELY. DUE TO THIS RECURRING ISSUE, THE CUSTOMER REQUESTED A FULL REPLACEMENT OF ALL REMAINING PRODUCTS FROM THE SAME LOT. THERE WERE NO SURGICAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094365 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987458 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987438 ↗
• MalfunctionApr 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SEPTOPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF. C-ARM WAS BROUGHT IN AND X-RAYS TAKEN WHICH VERIFIED NOTHING WAS IN THE NASAL CAVITY. THE PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT AND WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550181 ↗
• MalfunctionApr 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SEPTOPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE THE SURGEON WAS CLOSING IN THE NOSE, THE TIP OF THE NEEDLE BROKE OFF THE SUTURE. THE TIP OF THE NEEDLE WAS OBSERVED AND RETRIEVED AND DISPOSED OF IN THE SHARPS CONTAINER. THE PROCEDURE WAS DELAYED DUE THE EVENT AND WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550177 ↗

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.