PERMA-HAND K872HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031044586), received between Jun 13, 2019 and Mar 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE NEEDLES KEPT POPPING OFF THE SWEDGE. DEVICES ARE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559279 ↗
• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE NEEDLES KEPT POPPING OFF THE SWEDGE. DEVICES ARE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559273 ↗
• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE IN THE MOUTH, THE NEEDLE DETACHED FROM THE THREAD, CAUSING UNEASE TO THE PATIENT BECAUSE THE SUTURE COULDN'T BE COMPLETED. THE NEEDLE WAS REMOVED, AND ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279845 ↗
• MalfunctionNov 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYDROCELE RESECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN THE SALES REP GOT THE COMPLAINT PRODUCT AND CHECKED IT, HE FOUND THAT THE NEEDLE DID NOT DETACH BUT IT DID BREAK. AFTER THAT, HE ASKED ABOUT THE DETAILS THE SURGEON AND CONFIRMED THE FOLLOWING. DURING THE PROCEDURE, THE NEEDLE BROKE, AND IN ORDER TO SEARCH AND RETRIEVE THE BROKEN NEEDLE FROM THE BODY, ANOTHER TROCAR WAS INSERTED INTO THE BODY, ENDED UP MAKING ANOTHER WOUND. IN THE SURGEON'S JUDGMENT, IT WAS NOT SERIOUS BUT MODERATE. THE REASONS WERE THE WOUND WAS 2 MM LONGER THAN USUAL, AND THE OPERATION TIME WAS EXTENDED BY ABOUT 10 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780983 ↗
• MalfunctionAug 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING INTERRUPTED SUTURING ON ORAL. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176532 ↗
• MalfunctionJun 1, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS TO BE USED. IT WAS FOUND THAT THE NEEDLE-SUTURE HAD BEEN A DOUBLE-ARMED SUTURE ALTHOUGH IT SHOULD HAVE BEEN A SINGLE-ARMED SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914447 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CEREBRAL TUMERECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE PULLED OFF IMMEDIATELY DURING THE SUTURE OF THE DURA MATER. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696527 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CEREBRAL TUMORECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE PULLED OFF IMMEDIATELY DURING THE SUTURE OF THE DURA MATER. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696526 ↗

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-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.