PERMA-HAND 640GRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031007369), received between Dec 26, 2019 and Apr 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911196 ↗
• MalfunctionJan 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLE AND SUTURE WERE NOT ATTACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172689 ↗
• MalfunctionApr 9, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071726 ↗
• MalfunctionApr 9, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071725 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY BROKEN DURING USE EVEN THOUGH THE SURGEON DID NOT PUT TENSION TO IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809437 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN DENTAL AND ORAL SURGERY, ALTHOUGH THE SURGEON DIDN¿T PUT ANY TENSION TO IT, THE IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, ALTHOUGH THE SURGEON DIDN¿T PUT ANY TENSION TO IT, THE SUTURE BROKE DURING USE. THIS HAPPENED IN 2 PRODUCTS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715218 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN DENTAL AND ORAL SURGERY, ALTHOUGH THE SURGEON DIDN¿T PUT ANY TENSION TO IT, THE IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, ALTHOUGH THE SURGEON DIDN¿T PUT ANY TENSION TO IT, THE SUTURE BROKE DURING USE. THIS HAPPENED IN 2 PRODUCTS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715217 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THEIR CUSTOMER THAT THE SUTURE KEEPS BREAKING. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284920 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 23/10/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THEIR CUSTOMER THAT THE SUTURE KEEPS BREAKING. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284914 ↗
• MalfunctionJul 24, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379556 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED DENTAL ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN 2 SUTURES IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032981 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED DENTAL ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN 2 SUTURES IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032977 ↗
• MalfunctionOct 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE ORAL SURGERY, THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15684534 ↗
• MalfunctionOct 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE ORAL SURGERY, THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15684513 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PRODUCT WAS DEFECTIVE, THE SUTURE CONTINUES TO TEAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514081 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PRODUCT WAS DEFECTIVE, THE SUTURE CONTINUES TO TEAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514006 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PRODUCT WAS TEARING AND UNABLE TO BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14415142 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PRODUCT WAS TEARING AND UNABLE TO BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414722 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PRODUCT WAS TEARING AND UNABLE TO BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414688 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998682 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON 12/3/2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520765 ↗

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.