PDS Z495GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031061194), received between Mar 28, 2019 and May 14, 2025 — classified as 1 injury, 5 malfunctions.

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

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

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. Aug 10, 2023Open, Classified

   Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

   Z-2617-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT FIVE SUTURES BROKE WHILE TRYING TO CLOSE THE INCISION. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022235 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT FIVE SUTURES BROKE WHILE TRYING TO CLOSE THE INCISION. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022234 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT FIVE SUTURES BROKE WHILE TRYING TO CLOSE THE INCISION. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022233 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT FIVE SUTURES BROKE WHILE TRYING TO CLOSE THE INCISION. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022231 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT FIVE SUTURES BROKE WHILE TRYING TO CLOSE THE INCISION. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022229 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS PLACED IN THE RETRO-AURICULAR SKIN LAYER DURING CLOSURE OF A FACE-LIFT SURGERY. THE PLACEMENT OF SUTURES WAS INTERRUPTED. ON (B)(6) 2019, THE PATIENT RETURNED TO THE DOCTOR, COMPLAINING OF A FEVER AND INFECTION ALONG THE INCISION LINE. THE DOCTOR PRESCRIBED ANTIBIOTICS AND RELEASED THE PATIENT. THE PATIENT RETURNED ON (B)(6) 2019, REPORTING THE INFECTION HAS GOTTEN WORSE. THERE WERE NO SIGNS OF INFECTION PRIOR TO PROCEDURE. CULTURES WERE TAKEN AND SHOWED STAPH AUREUS. THE DOCTOR REOPERATED, REMOVED THE SUTURE, IRRIGATED THE INCISION LINE AND RESUTURED THE INCISION WITH A DIFFERENT SUTURE. THE PATIENT IS STABLE AND HAS BEEN TREATED WITH TEN DAYS OF ORAL BACTRIM. THE WOUND IS STABLE BUT STILL ERYTHEMATOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fever; Not Applicable; Unspecified Infection

  MAUDE report 8461761 ↗