Polysorb GL-128Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521045026), received between Jul 19, 2018 and Mar 6, 2023 — classified as 1 injury, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN APONEUROSIS WAS CLOSED, THE NEEDLE HAD BROKE. THE REMAINS OF THE NEEDLE WERE OUTSIDE THE PATIENT¿S CAVITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491739 ↗
• MalfunctionMar 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN APONEUROSIS WAS CLOSED, THE NEEDLE HAD BROKE. THE REMAINS OF THE NEEDLE WERE OUTSIDE THE PATIENT¿S CAVITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491615 ↗
• MalfunctionMar 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN APONEUROSIS WAS CLOSED, THE NEEDLE HAD BROKE. THE REMAINS OF THE NEEDLE WERE OUTSIDE THE PATIENT¿S CAVITY. A COMPETITOR SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486742 ↗
• MalfunctionJun 18, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, ON A CROSS STITCH SUTURE ON THE UTERINE MUSCLE FOR HEMOSTASIS OF NOT MORE THAN 500CC, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024560 ↗
• InjuryNov 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING GYNECOLOGIC EPISIOTOMY, NEEDLE DETACHED FROM THE THREAD. AN X-RAY WAS PERFORMED TO LOCATE/CONFIRM ALL PIECES WERE FOUND. SURGICAL TIME WAS EXTENDED BY 1 HOUR AND 30 MINUTES AS A RESULT OF THE SEARCH AND TIME NEEDED FOR CLOSURE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9322499 ↗
• MalfunctionJul 19, 2018Break

  ACCORDING TO THE REPORTER, BOTH NEEDLE AND THREAD BROKE DURING CAESAREAN SECTION. NEW SUTURE WAS TAKEN TO RESOLVE THE ISSUE AND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7703526 ↗

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