Polysorb CL-271Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521040458), received between Jul 7, 2017 and Nov 7, 2024 — classified as 2 malfunctions.

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

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.

• MalfunctionNov 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE REPLACEMENT SURGERY, THE OPERATION WENT SMOOTHLY BUT THE NON-ABSORBABLE SURGICAL SUTURE BROKE WHILE SUTURING THE PATIENT. TO RESOLVE THE ISSUE, NEW SUTURES WERE USED FOR THE PATIENT TO COMPLETE SUBSEQUENT SURGICAL SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20635211 ↗
• MalfunctionJul 7, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER RESECTION PROCEDURE, THE NEEDLE WAS BLUNT AND CAUSED BLEEDING. THE CUSTOMER IS REQUESTING THE DEVICE ANALYSIS TO UNDERSTAND THE REASON OF THE LIVER BLEEDING. THE DEVICE MUST BE BLIND-POINT NOT TO CAUSE THE BLEEDING. BLEEDING INHIBITOR WAS USED TO STOP THE BLEEDING AND THE CASE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY COMPLICATION. NO SURGICAL INTERVENTION WAS REQUIRED AND BLEEDING WAS NOT MORE THAN 500 CC'S. PATIENT STATUS IS ALIVE NO INJURY.

  Patient problems: No Code Available

  MAUDE report 6695591 ↗

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