Polysorb GLJ-54-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521045576), received between Jan 4, 2023 and Aug 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE OPENED THE PRODUCT, IT WAS FOUND TO BE HYDROLYZED AND THE SUTURE WAS TORN OR BROKEN. ANOTHER THREE SUTURES FROM THE SAME LOT WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599227 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, THREAD BREAKAGE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 16100001 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, THREAD BREAKAGE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 16099986 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC THYROIDECTOMY, AT THE TIME OF CLOSING THE SURGICAL INCISION, THREAD BREAKAGE OCCURRED WHEN LIGATION WAS PERFORMED AND THE KNOT WAS FIXATED. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097670 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, THREAD BREAKAGE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 16094192 ↗

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