PDS PDP777DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031218796), received between Sep 24, 2024 and Jan 16, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA AND DERMIS. THIS SURGERY WAS PERFORMED TO TREAT AN INJURY. DURING THE PROCEDURE, THE NEEDLE DETACHED EASIER THAN USUAL WHILE USING THE PRODUCT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100274 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA AND DERMIS. THIS SURGERY WAS PERFORMED TO TREAT AN INJURY. DURING THE PROCEDURE, THE NEEDLE DETACHED EASIER THAN USUAL WHILE USING THE PRODUCT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100267 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  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, THE CONTROL RELEASE NEEDLE WAS EASY TO DETACH. IT WAS 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 23927309 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED ON SUBCUTANEOUS TISSUE. POST-OP, THE PATIENT DEVELOPED AN INFECTION. WHEN OPENING THE AFFECTED AREA, IT WAS FOUND THAT THE PRODUCT CAUSED A CONDITION LIKE A SUTURE ABSCESS. WOUND IRRIGATION WAS PERFORMED. THE PATIENT IS CURRENTLY HOSPITALIZED. IT WAS STATED THAT THE SURGEON OPINED THAT A MONO-FILAMENT IS TINGLING AND TOUGH ON TISSUE, WHICH MAY HAVE CONTRIBUTED TO THE SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 23634503 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN DURING USE. THE BROKEN TIP WAS NOT FOUND, BUT TAKING AN X-RAY, THE DOCTOR JUDGED THAT THERE WERE NO PIECES LEFT INSIDE OF THE BODY, AND THE SURGERY WAS COMPLETED. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED 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 23574032 ↗
• MalfunctionAug 27, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT A NURSE NOTICED THAT THERE WAS A FOREIGN MATTER BEFORE USE. THIS EVENT WAS FOUND BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 22904582 ↗
• MalfunctionJan 15, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE CONTROL RELEASE NEEDLE COULD NOT BE DETACHED. SINCE THE PROBLEM OCCURRED IN THE 1ST PACKAGE AND THE SAME EVENT ALSO OCCURRED IN THE 2ND PACKAGE, SO THE DOCTOR DID NOT WANT TO USE THE REMAINING 6 PACKAGES, SO RETRIEVED AS A REFERENCE ITEM. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162147 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926528 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS BROKEN. THERE WAS NO BAD EFFECT TO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292299 ↗

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-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-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-1338-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
• 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-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.