Polysorb CL-953Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521043695), received between Oct 14, 2019 and May 10, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Unraveled Material” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE WOUND WAS OPENING UP A LITTLE BIT AT THE END OF THE INCISION FOLLOWING A PROCEDURE. ADDITIONAL SUTURE WAS USED WITHOUT AN ISSUE AND ANOTHER MANUFACTURER'S DEVICE WAS USED TO FIX THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 11797556 ↗
• InjuryMay 10, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE WOUND WAS OPENING UP A LITTLE BIT AT THE END OF THE INCISION FOLLOWING A PROCEDURE. ADDITIONAL SUTURE WAS USED WITHOUT AN ISSUE AND ANOTHER MANUFACTURER'S DEVICE WAS USED TO FIX THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 11797513 ↗
• InjuryApr 27, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, TWO WEEKS FOLLOWING AN OPEN ORTHOPEDIC PROCEDURE, WOUND WAS OPENING UP A LITTLE BIT AT THE END OF THE INCISION. ADDITIONAL SUTURE WAS USED WITHOUT AN ISSUE AND ANOTHER MANUFACTURER'S DEVICE WAS USED TO FIX THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 11735559 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A KNEE-REVISION PROCEDURE, THE PATIENT PRESENTED WITH SKIN BLISTERING AND PROTEUS MIRABILIS INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 9569267 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN TOTAL JOINT REPLACEMENT, WHEN THE DEVICE WAS USED IN AN INCISION CLOSURE, CASE WAS PERFORMED WITHOUT INCIDENT BUT AFTER 1 MONTH COMPLICATIONS AROSE.

  Patient problems: Tissue Damage

  MAUDE report 9186227 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN KNEE REPLACEMENT PROCEDURE, THE DEVICE WAS USED AND APPLIED TO CLOSE THE WOUND WITHOUT ANY PROBLEM. HOWEVER 1 MONTH POST-OPERATIVELY THE PATIENT HAD AN INFECTION. TO RESOLVE THE ISSUE THE PATIENT HAD TO USED IV ANTIBIOTIC THERAPY.

  Patient problems: Unspecified Infection

  MAUDE report 9186197 ↗

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