PERMA-HAND K945GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031044753), received between Oct 17, 2025 and Nov 7, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionNov 7, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PRACTITIONER DESCRIBES BREAKAGES OF THE THREAD AND/OR THE THREAD/NEEDLE JUNCTION DURING SUTURING IN THE IMPLANT SURGERY. THE INCIDENT OCCURRED DURING THE FIRST USE OF THE PRODUCT. THE PRACTITIONER HAS EXPERIENCE WITH THE USE OF THIS PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499022 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRACTITIONER REPORTS A RUPTURE OF THE SUTURE IN THE MOUTH IN A PATIENT. THIS INCIDENT FOLLOWS A FIRST REPORT MADE IN (B)(6) WHICH WAS NOT FOLLOWED UP DUE TO INSUFFICIENT INFORMATION: LOT NUMBER NOT COMMUNICATED, LACK OF DETAILS ON THE NATURE OF THE INCIDENT, AND IMPOSSIBILITY OF CONTACTING THE CUSTOMER. DURING THE CALL ON (B)(6) 2025, THE PRACTITIONER INDICATES THAT A NEW INCIDENT OF MOUTH BREAKAGE HAS OCCURRED, IN ADDITION TO THE THREE RUPTURES ALREADY MENTIONED IN THE INITIAL COMPLAINT. HE CLARIFIED THAT ALL THE WIRES CONCERNED, FOR BOTH ALERTS, CAME FROM THE SAME LOT: 107HPL. THE COLLECTION OF THE PRODUCTS COULD NOT BE ORGANIZED, THE PRACTITIONER NO LONGER HAVING THE ARTICLES CONCERNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324452 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRACTITIONER REPORTS A RUPTURE OF THE SUTURE IN THE MOUTH IN A PATIENT. THIS INCIDENT FOLLOWS A FIRST REPORT MADE IN AUGUST WHICH WAS NOT FOLLOWED UP DUE TO INSUFFICIENT INFORMATION: LOT NUMBER NOT COMMUNICATED, LACK OF DETAILS ON THE NATURE OF THE INCIDENT, AND IMPOSSIBILITY OF CONTACTING THE CUSTOMER. DURING THE CALL OF (B)(6) 2025, THE PRACTITIONER INDICATES THAT A NEW INCIDENT OF MOUTH BREAKAGE HAS OCCURRED, IN ADDITION TO THE THREE RUPTURES ALREADY MENTIONED IN THE INITIAL COMPLAINT. HE CLARIFIED THAT ALL THE WIRES CONCERNED, FOR BOTH ALERTS, CAME FROM THE SAME LOT: 107HPL. THE COLLECTION OF THE PRODUCTS COULD NOT BE ORGANIZED, THE PRACTITIONER NO LONGER HAVING THE ARTICLES CONCERNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324264 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRACTITIONER REPORTS A RUPTURE OF THE SUTURE IN THE MOUTH IN A PATIENT. THIS INCIDENT FOLLOWS A FIRST REPORT MADE IN AUGUST WHICH WAS NOT FOLLOWED UP DUE TO INSUFFICIENT INFORMATION: LOT NUMBER NOT COMMUNICATED, LACK OF DETAILS ON THE NATURE OF THE INCIDENT, AND IMPOSSIBILITY OF CONTACTING THE CUSTOMER. DURING THE CALL OF (B)(6) 2025, THE PRACTITIONER INDICATES THAT A NEW INCIDENT OF MOUTH BREAKAGE HAS OCCURRED, IN ADDITION TO THE THREE RUPTURES ALREADY MENTIONED IN THE INITIAL COMPLAINT. HE CLARIFIED THAT ALL THE WIRES CONCERNED, FOR BOTH ALERTS, CAME FROM THE SAME LOT: 107HPL. THE COLLECTION OF THE PRODUCTS COULD NOT BE ORGANIZED, THE PRACTITIONER NO LONGER HAVING THE ARTICLES CONCERNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324210 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRACTITIONER REPORTS A RUPTURE OF THE SUTURE IN THE MOUTH IN A PATIENT. THIS INCIDENT FOLLOWS A FIRST REPORT MADE IN AUGUST WHICH WAS NOT FOLLOWED UP DUE TO INSUFFICIENT INFORMATION: LOT NUMBER NOT COMMUNICATED, LACK OF DETAILS ON THE NATURE OF THE INCIDENT, AND IMPOSSIBILITY OF CONTACTING THE CUSTOMER. DURING THE CALL ON (B)(6) 2025, THE PRACTITIONER INDICATES THAT A NEW INCIDENT OF MOUTH BREAKAGE HAS OCCURRED, IN ADDITION TO THE THREE RUPTURES ALREADY MENTIONED IN THE INITIAL COMPLAINT. HE CLARIFIED THAT ALL THE WIRES CONCERNED, FOR BOTH ALERTS, CAME FROM THE SAME LOT: 107HPL. THE COLLECTION OF THE PRODUCTS COULD NOT BE ORGANIZED, THE PRACTITIONER NO LONGER HAVING THE ARTICLES CONCERNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324191 ↗

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.