PDS Z496GRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031061217), received between Nov 27, 2017 and May 1, 2026 — classified as 10 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (35 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. I ALSO RECEIVED A REPORT THAT THE CONDITION WAS THE SAME AS (B)(4), AND THE DOCTOR REPORTED THAT THE THREAD BROKE DURING THE SUTURING PROCESS, FEELING THAT IT WAS MORE FRAGILE THAN THE WIRE USED IN THE PAST. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056082 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR REPORTED THAT THE WIRE WAS PRONE TO BREAKAGE DURING SUTURING. (WHEN THE WIRE IS NOT CLAMPED WITH OTHER INSTRUMENTS AND THE WIRE IS PULLED BY HAND) AND IT HAS HAPPENED MANY TIMES, AND FINALLY I COULDN'T STAND IT BEFORE MAKING THIS REPORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049331 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR REPORTED THAT THE WIRE WAS PRONE TO BREAKAGE DURING SUTURING. (WHEN THE WIRE IS NOT CLAMPED WITH OTHER INSTRUMENTS AND THE WIRE IS PULLED BY HAND) AND IT HAS HAPPENED MANY TIMES, AND FINALLY I COULDN'T STAND IT BEFORE MAKING THIS REPORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049329 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, Z496G HAS MULTIPLE BROKEN WIRES DURING SUTURING, NOT NEEDLE AND THREAD SEPARATION BUT WIRE BREAKAGE, DETAILS WILL BE UPDATED AFTER VISITING A DOCTOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027797 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. WHILE USING THE ITEMS, THE DOCTOR REPORTED THAT THEY WERE BREAKING EASILY, REQUIRING REPLACEMENT AND EXCESSIVE USE OF THE THREADS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914575 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961630 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961629 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961628 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE IN HALF ON THE FIRST PASS THROUGH THE PATIENT'S SKIN, MAKING IT IMPOSSIBLE TO USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441342 ↗
• MalfunctionSep 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, THE NEEDLE AND THE THREAD WERE SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830792 ↗
• MalfunctionSep 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, THE NEEDLE AND THE THREAD WERE SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830714 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16733011 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732905 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732902 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732901 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732897 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732896 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON (B)(6) AND (B)(6) USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732892 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING JANUARY OR FEBRUARY OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON NOVEMBER 18 AND JANUARY 20. USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732890 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED FOR DERMAL SUTURE. AROUND 30 DAYS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL WITH STIFFNESS AND PAIN IN THE WOUND. THERE WAS INDURATION, REDNESS, AND PUS ALONG THE SUTURE. THE SALES REP CHECKED WITH COMPANIES THAT HANDLE LINEN AND SURGICAL INSTRUMENT DELIVERY RELATED COMPANIES TO SEE IF THEY HAD REPORTED ANY DEFECTS THAT HAD CAUSED SIMILAR CASES DURING (B)(6) OF THIS YEAR, BUT THEY RESPONDED THAT THEY HAD NOT. THIS TIME, THE SURGEON LIKELY USED THE PRODUCT PURCHASED ON (B)(6). USUALLY, ONLY A FEW CASES OF WOUND INFECTION OCCUR EACH YEAR. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS SEES A DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16732887 ↗
• MalfunctionMar 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, ALTHOUGH NO EXTRA TENSION WAS APPLIED, THE SUTURE BROKE AFTER THE 1ST STITCH DURING INTERRUPTED SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743292 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024608 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024605 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024597 ↗
• MalfunctionOct 29, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ABDOMINOPLASTY SURGERY ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10758877 ↗