ETHICON 1636GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031001497), received between Aug 27, 2020 and Dec 8, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940840 ↗
• InjuryAug 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT BUCCAL MUCOSA LACERATION REPAIR UNDER MODERATE SEDATION IN THE EMERGENCY DEPARTMENT ON (B)(6) 2020 AND THE SUTURE WAS USED. WHEN DURING THE FIRST PASS/SUTURE, THE SUTURE MATERIAL SEPARATED FROM THE NEEDLE. THE REPAIR PROCEDURE WAS IMMEDIATELY STOPPED, AND THE RECOVERY OF THE NEEDLE WAS ATTEMPTED BY THE ED PROVIDER TEAM AS WELL AS WITH A CONSULTING PEDIATRIC SURGEON, WITHOUT SUCCESS. THE NEEDLE BECAME LODGED IN THE CHEEK MUCOSA AND WAS VERIFIED WITH X-RAY. RATHER THAN CONTINUE TO ATTEMPT IN THE ED, THE PATIENT WAS MOVED TO OR FOR PATIENT SAFETY IN A CONTROLLED ENVIRONMENT. THE PATIENT UNDERWENT A RETRIEVAL AND EXTRACTION, LEFT BUCCAL SPACE NEEDLE, WITH REPAIR OF LEFT BUCCAL MUCOSAL LACERATION IN THE OR. THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION WITH PARENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10461437 ↗

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.