Polysorb GLS-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521045637), received between Sep 28, 2017 and Aug 11, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionAug 11, 2026Unraveled Material

  Patient problems: Impaired Healing; Inflammation; Wound Dehiscence

  MAUDE report 50204760 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SUBCUTANEOUS CELLULAR TISSUE IN A PATIENT WITH A THICK FATTY TISSUE, THE NEEDLE DETACHED FROM THE THREAD. IT FELL IN THE PATIENT¿S CAVITY. THE SURGEON HAD TO DISSECT INTO THE THICK FAT TO FIND THE NEEDLE AND RETRIEVE IT. AN ADDITIONAL SUTURE WAS USED WITHOUT AN ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21428753 ↗
• InjuryFeb 19, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INTERVENTIONAL RADIO SURGERY, THE DEVICE BROKE. THE NEEDLE CAME LOOSE FROM THE THREAD WHEN MAKING SUBCUTANEOUS STITCH. THE NEEDLE FELL INTO PATIENT'S CAVITY. SEARCH FOR THE NEEDLE WAS PERFORMED UNDER SCOPE AND NEW OPENING OF THE INTERVENTION AREA WAS MADE TO RETRIEVE THE NEEDLE FROM THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11349417 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF AN OPEN KNEE REPLACEMENT WHERE THE DEVICE WAS APPLIED DURING FASCIA CLOSURE USING THE CONTINUOUS SUTURING TECHNIQUE, THE PATIENT CAME BACK WITH GRANULOMA FROM SUBCUTANEOUS SUTURE ON BOTH DISTAL ENDS. THE PATIENT WAS REOPERATED TO EXCISE THE GRANULOMA. THE PATIENT WAS ALSO GIVEN ANTIBIOTICS. IT WAS STATED THAT THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Granuloma; No Code Available

  MAUDE report 8780753 ↗
• MalfunctionNov 26, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HERNIA REPAIR PROCEDURE, WHILE THE DEVICE WAS BEING USED FOR CLOSURE OF THE PERITONEUM, THE NEEDLE BROKE AND THE SUTURE TIP FELL INTO THE PATIENT'S CAVITY. NEEDLE TIP WAS RETRIEVED UNDER EYE VIEW, SEEN AND ABLE TO REMOVE AS SOON AS THE INCIDENT TOOK PLACE. OPENED A NEW PACKET AND CONTINUED TO CLOSE THE PERITONEUM. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8104753 ↗
• MalfunctionSep 28, 2017Component Missing; Component Missing

  ACCORDING TO THE REPORTER, ONE ENVELOPE WAS EMPTY AND HAD NO SUTURE AND NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900222 ↗

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