Polysorb CL-544Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521041080), received between May 12, 2022 and Oct 28, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE REMOVING FROM THE RETAINER OR PRIOR TO PATIENT INCISION, THE NEEDLE THREAD CAME LOOSE WHEN SLIGHTLY STRETCHED. IT OCCURRED ON SIX SUTURES. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401412 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE REMOVING FROM THE RETAINER OR PRIOR TO PATIENT INCISION, THE NEEDLE THREAD CAME LOOSE WHEN SLIGHTLY STRETCHED. IT OCCURRED ON SIX SUTURES. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401393 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE REMOVING FROM THE RETAINER OR PRIOR TO PATIENT INCISION, THE NEEDLE THREAD CAME LOOSE WHEN SLIGHTLY STRETCHED. IT OCCURRED ON SIX SUTURES. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401387 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE REMOVING FROM THE RETAINER OR PRIOR TO PATIENT INCISION, THE NEEDLE THREAD CAME LOOSE WHEN SLIGHTLY STRETCHED. IT OCCURRED ON SIX SUTURES. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401365 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE REMOVING FROM THE RETAINER OR PRIOR TO PATIENT INCISION, THE NEEDLE THREAD CAME LOOSE WHEN SLIGHTLY STRETCHED. IT OCCURRED ON SIX SUTURES. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401331 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE REMOVING FROM THE RETAINER OR PRIOR TO PATIENT INCISION, THE NEEDLE THREAD CAME LOOSE WHEN SLIGHTLY STRETCHED. IT OCCURRED ON SIX SUTURES. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393558 ↗
• MalfunctionMay 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN NAILING RIGHT FEMUR PROCEDURE, THE SUTURE KEPT ON BREAKING. THE SURGEON COMPLETED THE CASE USING THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14367236 ↗

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