PDS PDP968HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031048683), received between Jun 21, 2019 and Feb 28, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037, K212380); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THE SUTURE BROKE A LITTLE CLOSER TO THE NEEDLE SIDE THAN THE MIDDLE AT THE TIME OF SUTURING. THIS HAPPENED IN 2 PACKAGES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE NOT PROVIDED FROM THE HEALTHCARE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797298 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THE SUTURE BROKE A LITTLE CLOSER TO THE NEEDLE SIDE THAN THE MIDDLE AT THE TIME OF SUTURING. THIS HAPPENED IN 2 PACKAGES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE NOT PROVIDED FROM THE HEALTHCARE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797294 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE IN THE MIDDLE OF THE SUTURE DURING INSTRUMENT KNOT. THIS HAPPENED AT THE TIME OF SUBCUTANEOUS SUTURE AND THE PRODUCT WAS USED ON SUBCUTANEOUS DERMIS. SUTURE METHOD WAS INTERRUPTED SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796336 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(4) 2024 AND SUTURE WAS USED. THE SUTURE BROKE IN THE MIDDLE OF THE SUTURE DURING INSTRUMENT KNOT. THIS HAPPENED AT THE TIME OF SUBCUTANEOUS SUTURE AND THE PRODUCT WAS USED ON SUBCUTANEOUS DERMIS. SUTURE METHOD WAS INTERRUPTED SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796335 ↗
• MalfunctionOct 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962210 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE ABOUT TWO TIMES DURING USE. ANOTHER PRODUCT WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15452147 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL DECOMPRESSION SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT THE 1ST PASSING OF THE NEEDLE THROUGH THE SUBCUTIS BY CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8721003 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037, K212380. One submission often covers many models, so check the product and lot details in each record.

• Z-2147-2024 · May 10, 2024 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in oph
• Z-1571-2023 · Mar 31, 2023 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatri
• Z-1135-2019 · Mar 12, 2019 · Terminated
  VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SU
• Z-2532-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
• Z-2533-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
• Z-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
• Z-1340-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
• Z-1338-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
• Z-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.