Polysorb CL-904Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521042971), received between May 18, 2023 and Sep 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHEN THE DOCTOR WAS SUTURING TO CLOSE THE UTERUS AND TOOK A BITE OF THE TISSUE, THE NEEDLE DRIVER WAS USED TO PULL THE NEEDLE THROUGH, BUT WHEN THE USER GRABBED THE NEEDLE 1/3 OF THE WAY AWAY FROM THE NEEDLE POINT, IT BROKE INTO TWO PIECES. THE USER WATCHED THE DEVICE FALL INTO THE PATIENT'S CAVITY AND WAS ABLE TO PICK IT UP. IT WAS NOTED AS A COMPLETELY NORMAL CASE AND CLOSURE, WITH NO TOUGH TISSUE OR ANY ISSUES WITH SUTURING. THE SURGEON LEFT THE DEVICE STRAND IN THE PATIENT AND USED ANOTHER TYPE OF SUTURE TO TIE IT OFF AND FINISH THE CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128631 ↗
• MalfunctionMay 18, 2023Break; Dull, Blunt; Break; Dull, Blunt

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN SUTURING UP THE PATIENT, AFTER THE FIRST SUTURE, USER NOTICED THE NEEDLE WAS BLUNT AND PART OF THE END BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954780 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI