Polysorb GL-183Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521045088), received between Jun 28, 2019 and Dec 8, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CYST REMOVAL SURGERY, WHEN REMOVING THE SUTURE FROM THE SUPPORT, THE NEEDLE DETACHED FROM THE THREAD. THE NEEDLE WAS FOUND BUT THE EQUIPMENT WAS NOT PUT ASIDE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751994 ↗
• MalfunctionMar 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SPINAL SURGERY, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630837 ↗
• MalfunctionAug 27, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED DURING SUBCUTANEOUS SUTURE TECHNIQUE ON AN OPEN PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10458530 ↗
• MalfunctionAug 12, 2019Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVE, AFTER DIVERSE SUTURING TECHNIQUE WAS USED, THE DEVICE'S THREAD BROKE.

  Patient problems: No Patient Involvement

  MAUDE report 8882371 ↗
• InjuryJun 28, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AND THE NEEDLE WAS LEFT IN PATIENT'S BREAST. X-RAY WAS PERFORMED TO LOCATE AND RETRIEVE THE NEEDLE. THERE WAS AN EXTENDED DURATION OF INTERVENTION AND HOSPITALIZATION. A NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8746483 ↗

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