PDS PDP9910GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031461116), received between May 6, 2026 and May 6, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K061037); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP, (B)(6), BY MATERIALS MANAGER AT HOSPITAL, THAT AN ETHICON NEEDLE BROKE DURING A SURGERY. THE SURGEON FOR A TOTAL HIP ARTHROPLASTY, AND WHILE HIS PA, WAS USING PRODUCT PDP9910G WHILE CLOSING THE FASCIAL LAYER. AFTER HE USED IT FOR SEVERAL THROWS, HE NOTICED THE TIP WAS MISSING FROM THE NEEDLE. HE ASSUMED IT BROKE OFF AT SOME POINT WHILE HE WAS USING IT. THEY LOOKED FOR THE TIP BUT COULDN'T FIND IT SO AN X-RAY WAS TAKEN AND IT WAS DETERMINED THAT THE FRAGMENT WAS NOT IN THE PATIENT. THE CLOSING CONTINUED AND THE PATIENT WAS RECOVERING AS EXPECTED. THE BROKEN TIP DID ADD TIME TO THE CASE SINE AN X-RAY WAS NEEDED THAT WASN'T ORIGINALLY PLANNED. THE BROKEN NEEDLE WAS THEN DISCARDED INTO THE SHARPS CONTAINER. THERE WAS AN ATTEMPT TO RECOVER THE BROKEN NEEDLE IN ORDER TO SUBMIT AS PART OF THIS COMPLAINT, BUT IT WAS NOT FOUND. THE BOX THAT IT CAME FROM ALONG WITH 2 OTHER BOXES THAT HAVE THE SAME LOT NUMBER WERE PULLED FROM THE SHELF OUT OF AN ABUNDANCE OF CAUTION IN CASE SOMETHING WAS DEFECTIVE WITH OTHER PDP9910G SUTURE IN THE SAME LOT. PROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037. 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-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 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-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.