PDS Z493GRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705031061156), received between Nov 29, 2017 and Sep 30, 2026 — classified as 2 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947876 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374459 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN WHEN TIRED TO USE IT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085953 ↗
• MalfunctionJun 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE STERILIZATION EXPIRATION DATE OF THE PACKAGE WAS CROPPED OUT. THE STERILIZATION EXPIRATION DATE HAS BEEN PRINTED OUT OF THE DESIGNATED FIELD AND THE CORRECT INFORMATION COULD NOT BE READ. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624443 ↗
• MalfunctionJun 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE STERILIZATION EXPIRATION DATE OF THE PACKAGE WAS CROPPED OUT. THE STERILIZATION EXPIRATION DATE HAS BEEN PRINTED OUT OF THE DESIGNATED FIELD AND THE CORRECT INFORMATION COULD NOT BE READ. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624442 ↗
• MalfunctionDec 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 2 DEVICES WITH THE SAME ISSUE. NEEDLE SEPARATED FROM SUTURE DURING KNOTTING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392420 ↗
• MalfunctionDec 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 2 DEVICES WITH THE SAME ISSUE. NEEDLE SEPARATED FROM SUTURE DURING KNOTTING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392416 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON 21/11/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE DETERIORATED OR BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356195 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE DETERIORATED OR BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356190 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE DETERIORATED OR BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356186 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN DERMATOLOGIC PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, WHEN THE SURGEON PULLED THE SUTURE OF PDS5-0 A LITTLE BIT DURING SUTURE, THE SUTURE WAS BROKEN. IT IS UNKNOWN IF THE PRODUCT NUMBER - Z493G ¿ IS THE CORRECT PRODUCT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142566 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE SWAGE PART WHEN THE SURGEON APPLIED THE FIRST STITCH ON THE SKIN. THE NEEDLE WAS COLLECTED IMMEDIATELY. NO ADDITIONAL TREATMENT WAS PERFORMED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. . THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733303 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. POST-OP FROM (B)(6)2022 TO (B)(6)2023, THE PATIENT CAME BACK FOUR TIMES. ON (B)(6)2023, THE PATIENT'S INCISION WAS DEBRIDED AND A DIFFERENT SUTURE WAS USED AND PATIENT HEALED PROPERLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17171660 ↗
• MalfunctionMay 26, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE TIP WAS EASILY BENT AND THEN BROKEN DURING INTERRUPTED SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009502 ↗
• MalfunctionMay 26, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE TIP WAS EASILY BENT AND THEN BROKEN DURING INTERRUPTED SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009444 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD BROKE WHILE THE SURGEON SUTURED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15935963 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SUTURING. IT WAS POINTED OUT THAT THERE MAY BE NO NORMAL STRENGTH IN THE SUTURE. THE PART WHERE THE SUTURE BROKE WAS UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535565 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER MAKING THE FIRST STITCH, WHEN THE SUTURE WAS PULLED, IT BROKE. IT OCCURRED WITHOUT GRASPING WITH FORCEPS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427743 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, THERE WAS A SUTURE WITHOUT NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326373 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254120 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253995 ↗
• MalfunctionMar 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TYING A KNOT WITH AN INSTRUMENT DURING INTERRUPTED SUTURING, THE SUTURE WAS BROKEN AT THE 1ST LIGATION. AFTER THAT, THREE SUTURES WERE USED, BUT THE SAME ISSUE OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841452 ↗
• MalfunctionMar 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TYING A KNOT WITH AN INSTRUMENT DURING INTERRUPTED SUTURING, THE SUTURE WAS BROKEN AT THE 1ST LIGATION. AFTER THAT, THREE SUTURES WERE USED, BUT THE SAME ISSUE OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841451 ↗
• MalfunctionMar 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TYING A KNOT WITH AN INSTRUMENT DURING INTERRUPTED SUTURING, THE SUTURE WAS BROKEN AT THE 1ST LIGATION. AFTER THAT, THREE SUTURES WERE USED, BUT THE SAME ISSUE OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841449 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A HAND PROCEDURE IN (B)(6) 2020 AND SUTURE WAS USED FOR CLOSURE. SEVERAL WEEKS AFTER THE PROCEDURE, THE PATIENT STARTED BREAKING OUT AND HAS HAD FREQUENT DEGRANULATION'S "FLARE UPS" OF HER MAST CELL DISEASE SINCE THEN WHICH PUT HER INTO ANAPHYLACTIC SHOCK. WITH THE SUTURE, STARTED BREAKING OUT AROUND THE SITE WITH LOCALIZED MAST CELL REACTION AND PROBLEMS CASCADING FROM THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Anaphylactic Shock; Local Reaction

  MAUDE report 13636820 ↗