Polysorb GL-890Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521045538), received between Jul 31, 2018 and Jan 5, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TEETH RESECTION PROCEDURE, DURING THE SUTURING WITH A NEEDLE HOLDER THE NEEDLE AND THE THREAD WERE SEPARATED. THE THREAD LOST THE ATTACHMENT TO THE NEEDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101811 ↗
• MalfunctionDec 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TEETH RESECTION PROCEDURE, DURING SUTURING FROM OPEN JAW CAVITY VIA SINGLE KNOT SUTURE TECHNIQUE, WITH A NEEDLE HOLDER, THE NEEDLE BROKE AND THE THREAD WERE SEPARATED. THE THREAD LOST ITS ATTACHMENT TO THE NEEDLE. PRIOR TO USE THE ABSORBABLE SUTURE WAS OPENED OR REMOVED FROM THE PACKAGING FOR FIVE MINUTES. THE SURGEON REMOVED THE NEEDLE FROM THE NEEDLE HOLDER AND USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070987 ↗
• MalfunctionJul 31, 2018Break; Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING A DEEP LAYER OF THE SKIN OF THE ARM, BOTH THE NEEDLE AND THREAD BROKE AND THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED BY THE SURGEON. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7735321 ↗

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