Polysorb GLJ-57-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521045590), received between Apr 19, 2019 and Aug 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE GASTROINTESTINAL PROCEDURE, THE NEEDLE TIP BROKE. THE NEEDLE DID NOT FALL INTO THE PATIENT'S BODY. ANOTHER NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890231 ↗
• MalfunctionJul 15, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, SKIN CLOSURE OF THE LEFT ARM HEAD, THE TIP OF THE NEEDLE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505779 ↗
• MalfunctionJul 15, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING THE FOREARM IMPLANT INSERTION, WHEN ON SKIN SUTURING, THE THREAD GOT TANGLED AND COULD NOT COME OUT. ONE SIDE WAS RESECTED TO FIX THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 22505760 ↗
• MalfunctionJun 5, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE SUTURE BROKE AFTER JUST REMOVING IT FROM THE PACKAGING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467580 ↗
• MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PACEMAKER IMPLANTATION, THERE WAS A SUBCUTANEOUS SUTURE AND AN UNEXPECTED SEPARATION OF THE NEEDLE FROM THE THREAD. IT OCCURRED ON TWO DIFFERENT SUTURES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184566 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUB TOTAL GASTRECTOMY, WHEN THE SURGEON PERFORMED THE DETACHMENT OF THE PRODUCT AT DIGESTIVE TRACT ANASTOMOSIS, THE NEEDLE OF THE TWO DEVICES WAS PULLED OUT FROM THE THREAD WITH LITTLE FORCE THAN USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533708 ↗

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