Polysorb UL-46-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521049567), received between Mar 31, 2022 and Jun 8, 2022 — classified as 1 injury, 1 malfunction.

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.

• InjuryJun 8, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE CLOSING THE CHEST AREA, THE TIP OF THE NEEDLE BROKE OFF. THE SURGEON REOPENED, INSPECTED AND COULD NOT FIND TIP OF NEEDLE. AN X-RAY WAS TAKEN, BUT NO RETAINED ITEM. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE AS A RESULT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14635230 ↗
• MalfunctionMar 31, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF DURING THE FIRST PASS OF INTERRUPTED STITCH. ANOTHER DEVICE FROM THE SAME PACK WAS USED BUT THE NEEDLE BENT FROM THE FIRST PASS OF INTERRUPTED STITCH. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13970626 ↗

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