Polysorb CL-543Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521041073), received between Oct 24, 2018 and Apr 12, 2021 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2021Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WERE TWO INSTANCES WITH THIS SUTURE CODE AND LOT NUMBER. ONE NEEDLE WAS BENT AND THE TIP OF THE OTHER NEEDLE BROKE OFF WHILE SUTURING SOFT TISSUE. IN THE CASE WHERE THE NEEDLE TIP BROKE AND COULD NOT FOUND THE TIP, XRAY WAS DONE ON PATIENT BUT STILL IT COULD NOT FOUND. EVENTUALLY THEY FOUND THE TIP ON THE FLOOR. AND THIS TOOK AT LEAST 30 MINUTES OF ADDITIONAL OR TIME.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11648420 ↗
• InjuryAug 22, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN TOTAL KNEE PROCEDURE, THE PATIENT WOUND COMPLETELY DEHISCENCE. THE SURGEON HAD TO SUTURE TO RE-CLOSE THE WOUND.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 8921847 ↗
• MalfunctionOct 24, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, WHEN THEY OPENED THE PACK ONTO THE STERILE FIELD DURING A BILATERAL TOTAL KNEE ARTHROPLASTY, THEY NOTICED THAT THERE WERE 2 NEEDLES IN THE PACK WHICH SUPPOSED TO BE ONLY 1. THEY USED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000441 ↗

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