PDS Z423HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031060913), received between Jul 17, 2018 and Mar 18, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WITH USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633279 ↗
• MalfunctionJun 5, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN PASSING THE TISSUE BY THE NEEDLE, IT WAS NOTICED THAT THE SUTURE WAS COME OFF ALREADY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468379 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN GRAFTING FOR TATTOO PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED ON THE THIGH WITH INTERRUPTED SUTURING. POST-OP, ON (B)(6) 2023, A WOUND DEHISCENCE OCCURRED. THE SURGEON TREATED, BUT THE DETAIL WAS UNKNOWN. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS TREATED. THE SURGEON WILL FOLLOW-UP WITH THE PATIENT TILL RECOVERY. THE SURGEON OPINED THAT SINCE IT WAS A CHALLENGING CASE INVOLVING SKIN GRAFTING FOR A TATTOO, HE THOUGHT THE TROUBLE WAS KIND OF UNAVOIDABLE. THE SURGEON ALSO OPINED THAT THERE MAY BE A PROBLEM WITH TENSION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17774548 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17729211 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17729204 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17729201 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17729194 ↗
• MalfunctionMay 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE END OF THE SUTURE BROKE AWAY FROM THE END OF THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896150 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF A BASIL CANCER CELL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. WHILE SUTURING DEEP TISSUE IN AN INTERRUPTED LOOP, THE SUTURE BROKE WHILE TYING THE KNOT. A SECOND LIKE SUTURE WAS TRIED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359373 ↗
• MalfunctionFeb 21, 2019Break; Break

  FROM (B)(4): IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL CLOSURE OF A POST OPERATIVE WOUND ABOUT (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE BROKE WHILE TYING THE KNOT. A NEW SUTURE WAS USED WHEN THE ORIGINAL BROKE AND THERE WAS NO ADVERSE PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359365 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF A BASIL CANCER CELL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. WHILE SUTURING DEEP TISSUE IN AN INTERRUPTED LOOP, THE SUTURE BROKE WHILE TYING THE KNOT. THE DOCTOR USED SUTURE FROM A DIFFERENT PRODUCT CODE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359353 ↗
• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURES KEPT BREAKING DURING USE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693933 ↗