ETHILON 663GRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031007772), received between Feb 12, 2018 and Jul 9, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE NEEDLES IN THE 1 BOX HAS CONTAINED RUSTED NEEDLES. NO PATIENT IMPACT OR INVOLVEMENT WAS REPORTED BY CUSTOMER TO DISTRIBUTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706353 ↗
• MalfunctionJul 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE NEEDLES IN THE 1 BOX HAS CONTAINED RUSTED NEEDLES. NO PATIENT IMPACT OR INVOLVEMENT WAS REPORTED BY CUSTOMER TO DISTRIBUTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705997 ↗
• MalfunctionDec 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042420 ↗
• MalfunctionSep 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE AND SUTURE SEPARATED DURING SUTURING. THE NEEDLE WAS NOT LOST. SCRUB OPENED NEW SUTURES OF DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. NO DELAY DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109710 ↗
• MalfunctionSep 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE AND SUTURE SEPARATED DURING SUTURING. THE NEEDLE WAS NOT LOST. SCRUB OPENED NEW SUTURES OF DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. NO DELAY DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109708 ↗
• MalfunctionSep 4, 2019Break; Break

  IT WAS REPORTED BY A SALES REP THAT A PATIENT UNDERWENT AN A NAIL EXTRACTION SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. WHEN A NURSE TRIED TO STRAIGHTEN THE SUTURE, IT WAS BROKEN. ANOTHER PACKAGE WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959897 ↗
• MalfunctionMay 13, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8606176 ↗
• MalfunctionApr 10, 2019Material Separation; Material Separation

  IT WAS REPORTED DURING A BASIC SURGICAL SKILLS COURSE/SKILLS LAB ON AN UNKNOWN DATE SUTURE WAS USED. THE THREAD BROKE OFF FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500242 ↗
• MalfunctionApr 10, 2019Material Separation; Material Separation

  IT WAS REPORTED DURING A BASIC SURGICAL SKILLS COURSE/SKILLS LAB ON AN UNKNOWN DATE SUTURE WAS USED. THE THREAD BROKE OFF FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500239 ↗
• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE STRAND BROKE WHEN THE DOCTOR TRIED TO TIE A STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394254 ↗
• MalfunctionSep 20, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY THE STRING BROKE, AND EXCESSIVE FORCE WAS NOT ON THE STRING. THE CASE WAS COMPLETED WITH A REPLACEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896721 ↗
• MalfunctionFeb 12, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE COMPLETELY SEPARATED FROM THE THREAD. THE THREAD DID NOT BREAK AND THE NEEDLE REMAINED IN THE PATIENT¿S SKIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7264521 ↗

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.