ETHILON 2870GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031004160), received between Nov 13, 2019 and Apr 23, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR THE VASCULAR ANASTOMOSIS. IT WAS REPORTED THAT ONE NEEDLE COULD NOT BE FOUND. IT WAS POSSIBLE THAT THE NEEDLE WAS LEFT INSIDE OF THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19164046 ↗
• MalfunctionFeb 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOYAMOYA PROCEDURE IN (B)(6) OF 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY THE NEEDLE POPPED OFF THE SUTURE. THE NEEDLE WAS LOCATED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732733 ↗
• MalfunctionFeb 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEURO SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE WAS THICKER THAN USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9726917 ↗
• MalfunctionNov 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR MOYAMOYA ON (B)(6) 2019 AND SUTURE WAS USED TO SUTURE A BLOOD VESSEL TO THE BRAIN. DURING THE PROCEDURE, AFTER THE STITCH WAS TIED, THE NEEDLE WAS NOT ATTACHED TO THE SUTURE. IT WAS UNABLE TO BE FOUND IN THE FIELD (EXPOSED BRAIN SURFACE) USING AN OPERATIVE MICROSCOPE AND THOROUGH INSPECTION. THE CASE COMPLETED BY IMAGING AND THE PATIENT WAS CLOSED UP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314677 ↗
• MalfunctionNov 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR MOYAMOYA ON (B)(6) 2019 AND SUTURE WAS USED TO SUTURE A BLOOD VESSEL TO THE BRAIN. DURING THE PROCEDURE, AFTER THE SUTURE WAS TIED, IT WAS NOTICED THE NEEDLE WAS NOT ATTACHED TO THE SUTURE, BUT WAS EASILY FOUND IN THE FIELD. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314674 ↗

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-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.