PERMA-HAND 680HRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031008106), received between Mar 25, 2019 and Feb 21, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM #MW5164421, THE 0 SILK ON FSL (FOR SKIN LARGE) NEEDLE BEING USED TO SECURE CHEST TUBE. SMALL TIP OF NEEDLE BROKE OFF AND WAS NOT FOUND. X-RAY DONE BEFORE PRIOR TO LEAVING THE OR (OPERATING ROOM). DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432406 ↗
• MalfunctionJun 21, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT FOUND THAT THERE HAD BEEN A ONE FOREIGN MATTER IN THE STERILIZATION PACKAGE BY AN INSPECTION IN THE TESTING SECTION OF THE PLANT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588318 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174547 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174446 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174443 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174419 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174399 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174390 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931287 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931285 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931284 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931276 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931268 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A THREAD PACK WITH RED MARKED AND OPENED THREADS. THE PACKAGING BLISTER HAS THE RED MARKING AND THESE BLISTERS ARE ALSO OPEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931244 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING UNKNOWN TISSUE, WHEN THE DOCTOR PULLED THE SUTURE THROUGH THE TISSUE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929825 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE NOT PUTTING MUCH PRESSURE ON IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828362 ↗
• MalfunctionOct 16, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE. THE TIP OF NEEDLE WAS RETRIEVED BY THE PHYSICIAN. THE DEVICE IS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10692279 ↗
• MalfunctionMar 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VATS PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE THE DOCTOR WAS KNOTTING THE SUTURE, IT WAS BROKEN. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT OUTCOME WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450537 ↗
• MalfunctionMar 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VATS PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE THE DOCTOR WAS KNOTTING THE SUTURE, IT WAS BROKEN. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT OUTCOME WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450532 ↗
• MalfunctionMar 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VATS PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE THE DOCTOR WAS KNOTTING THE SUTURE, IT WAS BROKEN. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT OUTCOME WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450528 ↗

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.