PERMA-HAND C017DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031023499), received between Apr 25, 2018 and Jul 7, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A SPLIT IN THE SUTURE OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279130 ↗
• MalfunctionDec 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS EASY TO BREAK DURING THE SUTURING PROCESS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039560 ↗
• MalfunctionJun 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS NOTED THERE WAS PACKAGE DAMAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627489 ↗
• MalfunctionJan 5, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE, AND IT WAS REPORTED THE SUTURE PULLED OFF OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172433 ↗
• MalfunctionApr 27, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT PATIENT UNDERWENT UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS TO BE USED. DURING THE PROCEDURE, THE NEEDLE SIZE IS SAME WITH OTHER SAME PRODUCTS, BUT THE SIZE OF THREAD WAS THICKER THAN OTHERS. IT WAS NOT USED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7469500 ↗
• MalfunctionApr 25, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. DURING USE ON A PATIENT, IT WAS FOUND THAT THE SIZE WAS 1-0, NOT 3-0. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7462797 ↗

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.