Polysorb GL-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521044999), received between Apr 18, 2017 and Dec 18, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7124854 ↗
• MalfunctionDec 14, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD. NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119353 ↗
• InjuryApr 18, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: DURING OPEN HYSTERECTOMY PROCEDURE THE PART OF THE NEEDLE BROKE OFF WHILE SUTURING PELVIC TISSUE. X-RAY WAS USED TO TRY TO LOCATE THE BROKEN PIECE, SUSPECTED IDENTIFICATION ON (B)(6) 2017 BUT COULD NOT BE RETRIEVED / FOUND, THE SURGICAL TIME EXTENDED DUE TO THE PRODUCT PROBLEM. THE DEVICE HAD BEEN OPENED OR REMOVED FROM THE PACKAGING PRIOR TO USE FOR 5 MINUTES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. PATIENT STATUS : ALIVE- NO INJURY .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6499629 ↗

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