Polysorb GL-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521045187), received between Jul 1, 2019 and Apr 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROXIMAL GASTRECTOMY, WHEN THE SURGEON TRIED TO INSERT THE PRODUCT THROUGH A TROCAR FOR EXTRACORPOREAL LIGATION WHILE USING A METHOD OF MAKING A KNOT FROM OUTSIDE BODY AND GUIDING IT INTO BODY CAVITY AND LIGATING. THE NEEDLE CAME OFF WHEN ATTEMPTING TO PUT IT INTO THE PATIENT CAVITY  FROM THE TROCAR. THE NEEDLE DID NOT FALL INTO THE BODY CAVITY AND WAS RETRIEVED OUTSIDE THE BODY. A DIFFERENT TYPE OF SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14214472 ↗
• MalfunctionJul 1, 2019Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, SUTURE BROKE AND WOUND OPENED. PATIENT NEEDED EMERGENCY TREATMENT.

  Patient problems: No Code Available

  MAUDE report 8751578 ↗

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