Polysorb UL-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521049468), received between Jun 19, 2017 and Aug 23, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL EXPLORATION, WHEN THE SURGEON OPENED THE PACKAGING AND USED THE DEVICE TO SUTURE THE SURGICAL INCISION, THE SUTURE WAS FOUND IN A CRUSHED STATE AND COULD NOT BE USED AT ALL TO THE PATIENT. THE SUTURE ALSO BROKE. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278927 ↗
• MalfunctionJul 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYDROCELE TESTICLE RADICAL PROCEDURE, WHEN THE STITCHING WAS BEING PERFORMED WHILE CHANGING THE AREA NEAR THE SWAGE SEVERAL TIMES, THERE WAS A BREAK. THE NEEDLE AND THE THREAD WERE FOUND TO BE DISENGAGED. A NEW PRODUCT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15036571 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN DEVICE WAS REMOVED FROM THE PACKAGE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647994 ↗
• MalfunctionJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING SUTURING, THE NEEDLE ON THE SWEDGE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Information

  MAUDE report 8716742 ↗
• MalfunctionApr 10, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE ON FRACTURED FOREARM, THE SUTURE START TO UNTIE WHILE CLEANING THE SKIN AFTER SU TURING. THEY REMOVED THE SUTURE AND USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500627 ↗
• MalfunctionOct 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A ROUTINE SUTURING AFTER A CYST REMOVED ON AN AMBULATORY PROCEDURE, WHEN INSERTING THE NEEDLE UNDER THE DERMIS, THE NEEDLE BROKE. THE NEEDLE WAS RETRIEVED AND DISCARDED AND THE SUTURING WAS COMPLETED WITH ANOTHER NEEDLE OF THE SAME LOT NUMBER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990931 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A PHARYNX REBUILDING. THE SUTURE IS ABSORBABLE. MORE THAN ONE DEFECTIVE DEVICE WAS INVOLVED IN THE CASE, ALL OF THE SAME PRODUCT ID AND LOT NUMBER. THERE WAS TEMPORARY INJURY CAUSED RESULTING IN SALIVARY FISTULA AND NECK ABSCESS. THE PROBLEM CAUSED TISSUE DAMAGE WHICH WAS RESOLVED IN A SURGICAL TOILET IN AN ATTEMPT TO RECONSTRUCT THE PHARYNGEAL BREACH. AN ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6650262 ↗

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