Polysorb UL-246Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521049550), received between Nov 8, 2017 and Aug 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYST REMOVAL PROCEDURE, WHILE SEWING AT THE TIME OF FACIAL CLOSURE, THE SUTURE FRAYED AND SOME MATERIAL FELL INTO THE SITUS (CAVITY). THE SURGEON RETRIEVED THE MATERIAL FROM THE SITE AND USED A NEW SUTURE TO CLOSED THE FASCIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004477 ↗
• MalfunctionNov 8, 2019Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCEDURE, DURING WOUND CLOSURE WHILE USING THE SURGEONS KNOT SUTURING TECHNIQUE, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295332 ↗
• MalfunctionNov 8, 2017Break; Break

  ACCORDING TO THE REPORTER: PRIOR TO USE, THREE SUTURES HAD THE ISSUE THAT THE THREAD WAS BROKEN INTO PIECES FROM THE FIRST. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT: NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7010644 ↗

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