PDS Z507GRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031061293), received between Oct 29, 2018 and Nov 12, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE BROKE THE PRODUCT WAS USED ON SUBCUTANEOUS. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665356 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE BROKE THE PRODUCT WAS USED ON SUBCUTANEOUS. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664310 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE BROKE THE PRODUCT WAS USED ON SUBCUTANEOUS. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663568 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(4) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE-SUTURE WAS BROKEN IMMEDIATELY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514644 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE-SUTURE WAS BROKEN IMMEDIATELY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17513908 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN INTERRUPTED SUTURE WAS PERFORMED WITH THE PRODUCT ON DERMIS FOR WOUND CLOSURE, THE SURGEON REALIZED THAT THE NEEDLE TIP WAS BROKEN. THE OPERATION WAS TEMPORARILY STOPPED. AFTER THAT, THE SURGERY WAS CONTINUED, AND ANOTHER PRODUCT WAS USED TO CLOSE THE WOUND. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518895 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN INTERRUPTED SUTURE WAS PERFORMED WITH THE PRODUCT ON DERMIS FOR WOUND CLOSURE, THE SURGEON REALIZED THAT THE NEEDLE TIP WAS BROKEN. THE OPERATION WAS TEMPORARILY STOPPED. AFTER THAT, THE SURGERY WAS CONTINUED, AND ANOTHER PRODUCT WAS USED TO CLOSE THE WOUND. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518892 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN INTERRUPTED SUTURE WAS PERFORMED WITH THE PRODUCT ON DERMIS FOR WOUND CLOSURE, THE SURGEON REALIZED THAT THE NEEDLE TIP WAS BROKEN. THE OPERATION WAS TEMPORARILY STOPPED. AFTER THAT, THE SURGERY WAS CONTINUED, AND ANOTHER PRODUCT WAS USED TO CLOSE THE WOUND. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518891 ↗
• InjuryNov 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN. AT THAT TIME, IT WAS JUDGED THAT THERE WAS NO RESIDUE IN THE BODY AND THE WOUND WAS CLOSED. HOWEVER, ONE WEEK AFTER THE SURGERY, AN X-RAY REVEALED THAT IT WAS IN THE DERMIS. HOW TO PROCEED IS UNDER DISCUSSION CURRENTLY, AND IT IS HIGHLY LIKELY THAT A REOPERATION WILL BE PERFORMED FOR REMOVAL. THE PATIENT'S CONDITION WAS GOOD AFTER THE INITIAL SURGERY. NO SECONDARY HEALTH HAZARD DUE TO RETAINED NEEDLE HAS BEEN IDENTIFIED. THOUGH THE NEEDLE PIECE IS STILL LEFT IN PATIENT, THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12865555 ↗
• MalfunctionSep 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484593 ↗
• MalfunctionAug 27, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE HAD BEEN SUTURE FROM A DIFFERENT PRODUCT CODE IN A BOX OF SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380374 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A LAPAROSCOPIC GASTRECTOMY AND CHOLECYSTECTOMY PROCEDURE WAS PERFORMED AND SUTURE WAS USED. DURING THE DERMAL SUTURING, THE NEEDLE COULD NOT BE PASSED SMOOTHLY THROUGH THE SECOND STITCH. WHEN CHECKING THE NEEDLE IT APPEARED BROKEN OR CRUSHED. 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 12235068 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHEN CLOSING THE SURGICAL WOUND, AFTER PUTTING 3 STITCHES, IT BECAME HARD TO PASS THE NEEDLE THROUGH THE TISSUE. SO, WHEN CHECKING THE NEEDLE, THE NEEDLE TIP HAD BEEN BROKEN. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162377 ↗
• MalfunctionApr 14, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, WHEN PUTTING THE FIRST STITCH, IT WAS FOUND THAT A PART OF THE SUTURE HAD BEEN TORN, SO USE WAS STOPPED. IT IS UNKNOWN WHETHER THE SUTURE HAD BEEN TORN WHEN OPENING THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668785 ↗
• MalfunctionAug 28, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN CAUGHT AT THE EDGE OF THE PACKAGE. WHEN OPENING THE PACKAGE, THE SUTURE FELL ONTO AN UNCLEAN AREA WITH THE PACKAGE. THE SURGEON WAS GUESSING THAT THE SUTURE MIGHT HAVE BEEN CAUGHT AT THE EDGE OF THE PACKAGE WHEN THE PACKAGE HAD BEEN SEALED. THE PROVIDED PHOTO WAS SHOWING THE SUTURE PASSED THROUGH THE SEALING AREA. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466568 ↗
• MalfunctionJul 20, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809858 ↗
• MalfunctionOct 29, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015140 ↗