Polysorb GL-129Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521045033), received between Apr 17, 2018 and Aug 26, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A CESAREAN SECTION, THE NEEDLE BROKE IN TWO WHILE SUTURING THE UTERUS. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896548 ↗
• MalfunctionFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY CESAREAN, WHILE SUTURING, THE NEEDLE BECAME LOOSE AND FELL INTO THE PATIENT'S CAVITY. IT WAS NOTED THAT THE NEEDLE REMAINED PLANTED IN THE WALL OF THE UTERUS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349550 ↗
• MalfunctionJan 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, WHILE CLOSING THE UTERINE, THE THREAD OF TWO SUTURES WERE BROKEN. THE SURGEON USED A THIRD SUTURE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359975 ↗
• MalfunctionJan 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, WHILE CLOSING THE UTERINE, THE THREAD OF TWO SUTURES WERE BROKEN. THE SURGEON USED A THIRD SUTURE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359931 ↗
• MalfunctionJan 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE CLOSING THE APONEUROSIS, THE NEEDLE BROKE. THE SURGEON TOOK BACK BOTH PART OF THE BROKEN NEEDLE AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359737 ↗
• MalfunctionJul 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, LAPAROSCOPIC GYNECOLOGY PROCEDURE, THE DEVICE NEEDLE WAS SEPARATED FROM THE STRAND. TO RESOLVE THE ISSUE, THE SURGEON JOINED THE STRAND WITH SINGLE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337521 ↗
• MalfunctionDec 7, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8144069 ↗
• InjuryNov 15, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE BREAK AND PART OF IT FELL INTO THE PATIENT CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8076179 ↗
• MalfunctionApr 17, 2018Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, A ¿SURJET¿ SUTURING TECHNIQUE WAS EMPLOYED BY THE SURGEON, BUT AT THE END OF THE OPEN PROCEDURE, THE FIRST AND SECOND SUTURE HAD THREAD BROKEN BUT THE OTHER ONE HAD NEEDLE SEPARATED FROM THE THREAD AND FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED BY THE SURGEON. THE FIRST DOCTOR TOOK ANOTHER SUTURE BUT THE NEEDLE QUICKLY TWISTED AND THEN THE SECOND DOCTOR TOOK ANOTHER SUTURE AND IT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436749 ↗

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