PDS Z497GRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031061231), received between Sep 27, 2019 and Dec 9, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PORT INSERTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE DID NOT SEEM TO BE DISSOLVING, SKIN INFECTION RESULTED, TREATED WITH KEFLEX AND THE PORT THEN ERODED THROUGH THE SKIN. THESE ARE THE SAME SUTURES WE HAVE USED OVER THE PAST 13 YEARS WITH NO SUCH INCIDENT. I HAVE BEEN SEEING A LOT NOT DISSOLVING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23758292 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. A FEW DAYS POST OP THE PATIENT'S INCISION DEHISCED. THE INCISION WAS RE-CLOSED WITH A DIFFERENT TYPE OF SUTURE. PATIENT CURRENT STATUS WAS NOT GIVEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 19164656 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, ALTHOUGH THE SURGEON DID NOT BITE THE PRODUCT WITH FORCEPS, THE SUTURE WAS BROKEN IMMEDIATELY DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273855 ↗
• MalfunctionNov 22, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THEY WERE USING THE SUTURE TO CLOSE WOUND, THE SUTURES WERE FRAYING AND BREAKING. ANOTHER BOX WITH A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849502 ↗
• MalfunctionNov 22, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THEY WERE USING THE SUTURE TO CLOSE WOUND, THE SUTURES WERE FRAYING AND BREAKING. ANOTHER BOX WITH A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848622 ↗
• MalfunctionNov 18, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN TRYING TO USE THE SUTURES AND PUT IT IN PLACE, THE SUTURES WERE FRAYING THEN BREAKING. A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822814 ↗
• MalfunctionNov 17, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN TRYING TO USE THE SUTURES AND PUT IT IN PLACE, THE SUTURES WERE FRAYING THEN BREAKING. A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815845 ↗
• MalfunctionNov 17, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN TRYING TO USE THE SUTURES AND PUT IT IN PLACE, THE SUTURES WERE FRAYING THEN BREAKING. A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815843 ↗
• MalfunctionNov 17, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON 10/17/2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN TRYING TO USE THE SUTURES AND PUT IT IN PLACE, THE SUTURES WERE FRAYING THEN BREAKING. A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815838 ↗
• MalfunctionNov 17, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN TRYING TO USE THE SUTURES AND PUT IT IN PLACE, THE SUTURES WERE FRAYING THEN BREAKING. A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815837 ↗
• MalfunctionNov 17, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN TRYING TO USE THE SUTURES AND PUT IT IN PLACE, THE SUTURES WERE FRAYING THEN BREAKING. A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815762 ↗
• MalfunctionJun 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT THAT THEY HAVE THREE BOXES OF SUTURES THAT THEY KEEP SNAPPING OFF OF THE NEEDLES. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14689778 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT REPORTED THAT THE DEVICE IS BREAKING TOO EASY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538436 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT REPORTED THAT THE DEVICE IS BREAKING TOO EASY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538354 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT REPORTED THAT THE DEVICE IS BREAKING TOO EASY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538314 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130941 ↗