PDS Z117HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031060166), received between Jul 3, 2018 and Jul 2, 2025 — classified as 3 injuries, 8 malfunctions.

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

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382048 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177894 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177886 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177885 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177882 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177877 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, USE COMPETITOR BECAUSE IT BREAKS OFF EVERY TIME SURGEON DO KNOT TYING AS CR SUTURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000876 ↗
• InjuryFeb 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT HAD SUPERFICIAL STITCHES. POST-OP, THE SUTURE EITHER BROKE OR STRETCHED AND WASN'T HEALING CORRECTLY. THE SURGEON OPINED THAT IT SEEMED OUT OF THE ORDINARY FOR IT TO REOPEN SOME OR BREAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 18813238 ↗
• InjuryFeb 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT HAD SUPERFICIAL STITCHES. POST-OP, THE SUTURE EITHER BROKE OR STRETCHED AND WASN'T HEALING CORRECTLY. THE SURGEON OPINED THAT IT SEEMED OUT OF THE ORDINARY FOR IT TO REOPEN SOME OR BREAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 18813237 ↗
• InjuryFeb 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT HAD SUPERFICIAL STITCHES. POST-OP, THE SUTURE EITHER BROKE OR STRETCHED AND WASN'T HEALING CORRECTLY. THE SURGEON OPINED THAT IT SEEMED OUT OF THE ORDINARY FOR IT TO REOPEN SOME OR BREAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 18813230 ↗
• MalfunctionJul 3, 2018Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS FOUND THAT THE SUTURE NEAR THE SWAGE PART WAS TOO THIN WHEN OPENING THE PACKAGE. THE NEEDLE-SUTURE IN QUESTION COULD NOT BE USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658907 ↗