PERMA-HAND 683GRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031008175), received between Jan 17, 2018 and Feb 17, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN THE WARDS/ICU, THE SUTURE WAS BROKEN IMMEDIATELY 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369217 ↗
• MalfunctionJul 1, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THIS SUTURE HAS NO EXPIRATION DATE. NO ADVERSE IMPACT TO PATIENT/USER WAS REPORTED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372198 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582577 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582568 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582476 ↗
• 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 19071728 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439790 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439786 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439785 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439782 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439779 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439777 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, WHEN THE PRODUCT WAS HELD WITH A NEEDLE HOLDER, THE SUTURE BROKE. THE SUTURE DETERIORATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439770 ↗
• MalfunctionOct 20, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN IMMEDIATELY DURING USE. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707245 ↗
• MalfunctionOct 2, 2020Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10623383 ↗
• MalfunctionMar 15, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DENTAL FLAP SURGERY PROCEDURE ON AN (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING INTERRUPTED SUTURING ON THE GUM. THE SWAGE PART WAS NOT HELD. WHEN PULLING THE SUTURE AFTER THE SUTURING, THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. NO BROKEN PIECES OF THE NEEDLE WERE LEFT INSIDE THE PATIENT¿S BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425842 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS COMMENTED THAT SUTURE BREAKAGES OCCURRED EASILY IN THE SAME LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169149 ↗
• MalfunctionOct 3, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANT PLACEMENT IN THE MOUTH ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930109 ↗
• MalfunctionOct 3, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANT PLACEMENT IN THE MOUTH ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930035 ↗
• MalfunctionJan 17, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7198587 ↗

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.