ETHILON 9000GRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031022300), received between Apr 6, 2018 and Jun 17, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CATARACT PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT CUSTOMER STATED TWO NEEDLES IN THE BOX BROKE IN HALF WHEN THEY TRIED TO LOAD IT ONTO THE NEEDLE HOLDER. NO ONE WAS INJURED BUT THERE IS A POTENTIAL INJURY POSSIBLE. 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 25535695 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CATARACT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE ACCOUNT CONTACT THAT PRIOR TO A CATARACT PROCEDURE, THE DEVICE COULD NOT BE LOADED AS IT REPEATEDLY SNAPPED DURING LOADING AND DID NOT ADVANCE PAST THE INITIAL STAGE. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488092 ↗
• MalfunctionApr 27, 2026Break; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED EYE PROCEDURE, SURGEONS EXPERIENCED ISSUES WITH THE SUTURES. THE SURGEONS COMPLAINED THAT THE SUTURES WERE NOT ONLY SNAPPING BUT ALSO BENDING DURING USE. THEY ALSO FELT THAT THE SUTURES DID NOT APPEAR TO BE AS SHARP AS NORMAL, WHICH CAUSED DIFFICULTY DURING SUTURING. DUE TO THESE ISSUES, THE SURGEONS HAD TO CAREFULLY REMOVE THE BROKEN SUTURE AND PROCEED WITH ANOTHER SUTURE TO COMPLETE THE PROCEDURE, DOING SO AT A MUCH SLOWER PACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001407 ↗
• MalfunctionApr 27, 2026Break; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED EYE PROCEDURE, SURGEONS EXPERIENCED ISSUES WITH THE SUTURES. THE SURGEONS COMPLAINED THAT THE SUTURES WERE NOT ONLY SNAPPING BUT ALSO BENDING DURING USE. THEY ALSO FELT THAT THE SUTURES DID NOT APPEAR TO BE AS SHARP AS NORMAL, WHICH CAUSED DIFFICULTY DURING SUTURING. DUE TO THESE ISSUES, THE SURGEONS HAD TO CAREFULLY REMOVE THE BROKEN SUTURE AND PROCEED WITH ANOTHER SUTURE TO COMPLETE THE PROCEDURE, DOING SO AT A MUCH SLOWER PACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001406 ↗
• MalfunctionApr 27, 2026Break; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNSPECIFIED EYE PROCEDURE, SURGEONS EXPERIENCED ISSUES WITH THE SUTURES. THE SURGEONS COMPLAINED THAT THE SUTURES WERE NOT ONLY SNAPPING BUT ALSO BENDING DURING USE. THEY ALSO FELT THAT THE SUTURES DID NOT APPEAR TO BE AS SHARP AS NORMAL, WHICH CAUSED DIFFICULTY DURING SUTURING. DUE TO THESE ISSUES, THE SURGEONS HAD TO CAREFULLY REMOVE THE BROKEN SUTURE AND PROCEED WITH ANOTHER SUTURE TO COMPLETE THE PROCEDURE, DOING SO AT A MUCH SLOWER PACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001343 ↗
• MalfunctionApr 27, 2026Break; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNSPECIFIED EYE PROCEDURE, SURGEONS EXPERIENCED ISSUES WITH THE SUTURES. THE SURGEONS COMPLAINED THAT THE SUTURES WERE NOT ONLY SNAPPING BUT ALSO BENDING DURING USE. THEY ALSO FELT THAT THE SUTURES DID NOT APPEAR TO BE AS SHARP AS NORMAL, WHICH CAUSED DIFFICULTY DURING SUTURING. DUE TO THESE ISSUES, THE SURGEONS HAD TO CAREFULLY REMOVE THE BROKEN SUTURE AND PROCEED WITH ANOTHER SUTURE TO COMPLETE THE PROCEDURE, DOING SO AT A MUCH SLOWER PACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001342 ↗
• MalfunctionApr 27, 2026Break; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNSPECIFIED EYE PROCEDURE, SURGEONS EXPERIENCED ISSUES WITH THE SUTURES. THE SURGEONS COMPLAINED THAT THE SUTURES WERE NOT ONLY SNAPPING BUT ALSO BENDING DURING USE. THEY ALSO FELT THAT THE SUTURES DID NOT APPEAR TO BE AS SHARP AS NORMAL, WHICH CAUSED DIFFICULTY DURING SUTURING. DUE TO THESE ISSUES, THE SURGEONS HAD TO CAREFULLY REMOVE THE BROKEN SUTURE AND PROCEED WITH ANOTHER SUTURE TO COMPLETE THE PROCEDURE, DOING SO AT A MUCH SLOWER PACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001341 ↗
• MalfunctionApr 27, 2026Break; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNSPECIFIED EYE PROCEDURE, SURGEONS EXPERIENCED ISSUES WITH THE SUTURES. THE SURGEONS COMPLAINED THAT THE SUTURES WERE NOT ONLY SNAPPING BUT ALSO BENDING DURING USE. THEY ALSO FELT THAT THE SUTURES DID NOT APPEAR TO BE AS SHARP AS NORMAL, WHICH CAUSED DIFFICULTY DURING SUTURING. DUE TO THESE ISSUES, THE SURGEONS HAD TO CAREFULLY REMOVE THE BROKEN SUTURE AND PROCEED WITH ANOTHER SUTURE TO COMPLETE THE PROCEDURE, DOING SO AT A MUCH SLOWER PACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001340 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT DURING AN OPTHAMOLOGY CASE WHEN USING THE SUTURE, THE NEEDLE BROKE AND SHARDS SHATTERED OFF OF IT. NO PATIENT CONSEQUENCES, AND THEY WERE ABLE TO GET AN ADDITIONAL SUTURE (FROM THE SAME BOX) TO FINISH THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011878 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER, THAT ONE OF THEIR SURGEONS STATED THE SUTURE HE HAS BEEN USING FOR YEARS SEEMS TO HAVE SOMETHING WRONG. THE SURGEON STATED THAT THE TIP OF THE SUTURE GOES IN SMOOTH, BUT THE END SEEMS TO BE WIDER. HE STATED THAT THE SUTURE PART IS WIDER OR LARGER THAN THE TIP OF THE NEEDLE, SO THAT IT CAUSES HIM TO TUG ON IT. THREE OF THE SIX SUTURES HE USED WERE BAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED. STERILE SUTURES LEFT OVER FROM SAME LOT TO BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563330 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER, THAT ONE OF THEIR SURGEONS STATED THE SUTURE HE HAS BEEN USING FOR YEARS SEEMS TO HAVE SOMETHING WRONG. THE SURGEON STATED THAT THE TIP OF THE SUTURE GOES IN SMOOTH, BUT THE END SEEMS TO BE WIDER. HE STATED THAT THE SUTURE PART IS WIDER OR LARGER THAN THE TIP OF THE NEEDLE, SO THAT IT CAUSES HIM TO TUG ON IT. THREE OF THE SIX SUTURES HE USED WERE BAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED. STERILE SUTURES LEFT OVER FROM SAME LOT TO BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563206 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER, THAT ONE OF THEIR SURGEONS STATED THE SUTURE HE HAS BEEN USING FOR YEARS SEEMS TO HAVE SOMETHING WRONG. THE SURGEON STATED THAT THE TIP OF THE SUTURE GOES IN SMOOTH, BUT THE END SEEMS TO BE WIDER. HE STATED THAT THE SUTURE PART IS WIDER OR LARGER THAN THE TIP OF THE NEEDLE, SO THAT IT CAUSES HIM TO TUG ON IT. THREE OF THE SIX SUTURES HE USED WERE BAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED. STERILE SUTURES LEFT OVER FROM SAME LOT TO BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563202 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER, THAT ONE OF THEIR SURGEONS STATED THE SUTURE HE HAS BEEN USING FOR YEARS SEEMS TO HAVE SOMETHING WRONG. THE SURGEON STATED THAT THE TIP OF THE SUTURE GOES IN SMOOTH, BUT THE END SEEMS TO BE WIDER. HE STATED THAT THE SUTURE PART IS WIDER OR LARGER THAN THE TIP OF THE NEEDLE, SO THAT IT CAUSES HIM TO TUG ON IT. THREE OF THE SIX SUTURES HE USED WERE BAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED. STERILE SUTURES LEFT OVER FROM SAME LOT TO BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563200 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER, THAT ONE OF THEIR SURGEONS STATED THE SUTURE HE HAS BEEN USING FOR YEARS SEEMS TO HAVE SOMETHING WRONG. THE SURGEON STATED THAT THE TIP OF THE SUTURE GOES IN SMOOTH, BUT THE END SEEMS TO BE WIDER. HE STATED THAT THE SUTURE PART IS WIDER OR LARGER THAN THE TIP OF THE NEEDLE, SO THAT IT CAUSES HIM TO TUG ON IT. THREE OF THE SIX SUTURES HE USED WERE BAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED. STERILE SUTURES LEFT OVER FROM SAME LOT TO BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563197 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER, THAT ONE OF THEIR SURGEONS STATED THE SUTURE HE HAS BEEN USING FOR YEARS SEEMS TO HAVE SOMETHING WRONG. THE SURGEON STATED THAT THE TIP OF THE SUTURE GOES IN SMOOTH, BUT THE END SEEMS TO BE WIDER. HE STATED THAT THE SUTURE PART IS WIDER OR LARGER THAN THE TIP OF THE NEEDLE, SO THAT IT CAUSES HIM TO TUG ON IT. THREE OF THE SIX SUTURES HE USED WERE BAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED. STERILE SUTURES LEFT OVER FROM SAME LOT TO BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563151 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THEY ARE HAVING ISSUES WITH THIS SUTURE BREAKING OFF THE NEEDLES WHILE IN USE AND WHEN WE LOAD. IT HAS HAPPENED QUITE A FEW TIMES NOW. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465582 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY ARE HAVING ISSUES WITH THIS SUTURE BREAKING OFF THE NEEDLES WHILE IN USE AND WHEN WE LOAD. IT HAS HAPPENED QUITE A FEW TIMES NOW. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465562 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY ARE HAVING ISSUES WITH THIS SUTURE BREAKING OFF THE NEEDLES WHILE IN USE AND WHEN WE LOAD. IT HAS HAPPENED QUITE A FEW TIMES NOW. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465502 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORNEAL TRANSPLANT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THERE WAS SOME RESISTANCE TO NEEDLE MOVEMENT DURING CONTINUOUS SUTURE, BUT THE SURGEON MANAGED TO PROCEED WITH THE SUTURE, BUT WHEN HE CHECKED THE BASE OF THE NEEDLE, HE FOUND THAT PART OF THE METAL PART OF THE NEEDLE HAD BROKEN OFF AT THE SWAGE. THE BROKEN PART WAS QUICKLY FOUND AND RETRIEVED DURING THE SAME PROCEDURE. BECAUSE THE NEEDLE WAS A DOUBLE-ARMED SUTURE, HE COMPLETED THE OPERATION WITH THE OTHER NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135240 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL CORNEA TRANSPLANT/DMEK PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN THEY WENT TO LOAD THE NEEDLE IT BROKE. IT WAS RETRIEVED AND A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848738 ↗
• MalfunctionApr 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043882 ↗
• MalfunctionAug 20, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348987 ↗
• MalfunctionAug 20, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348976 ↗
• MalfunctionAug 20, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348958 ↗
• MalfunctionAug 20, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348955 ↗

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.