Polysorb CL-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521041912), received between Nov 7, 2021 and Oct 9, 2023 — 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.

• InjuryOct 9, 2023Break; 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 EPISIOTOMY PERFORMED AFTER A VAGINAL BIRTH, A NEEDLE BROKE DURING THE INITIAL STITCHING BY THE SURGEON. THE BROKEN PART OF THE NEEDLE COULD NOT BE LOCATED, PROMPTING THE USE OF A MOBILE X-RAY MACHINE. EVENTUALLY, THE PATIENT HAD TO BE TAKEN TO THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT, WHERE ANOTHER SURGEON SUCCESSFULLY FOUND AND REMOVED THE BROKEN NEEDLE. THIS EXTENDED THE SURGICAL PROCEDURE BY OVER 30 MINUTES, AND THE PATIENT REQUIRED RE-STITCHING.

  Patient problems: Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 17897444 ↗
• MalfunctionNov 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY BYPASS GRAFT, TWO STRANDS OF THE SUTURE BROKE WHILE CLOSING. AFTER THE SECOND INCIDENT, THE SURGEON SWITCHED TO A DEVICE FROM DIFFERENT MANUFACTURER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760240 ↗

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