Polysorb CL-918Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521043367), received between May 21, 2019 and May 8, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, AFTER AN ABDOMINAL SKIN FLAP DISSECTION OF THE LEFT HAND, DEBRIDEMENT OF NECROTIC TISSUE, AND SKIN GRAFTING PROCEDURE, WHEN CHANGING THE DRESSING OF THE PATIENT'S WOUND, IT WAS DISCOVERED THAT THE MICROBRIDGE LINE OF THE INCISION, ABOUT 1 CENTIMETER IN THE LEFT ABDOMEN, WAS EXPOSED, WITH A LITTLE EXUDATION, AND THE SURROUNDING SKIN WAS RED AND HAD A SKIN RASH. AFTERREPORTING TO THE SURGEON, THE PATIENT HAD THE EXPOSED THREAD REMOVED AND THE DRESSING CHANGED. TWELVE DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT'S WOUND SYMPTOMS SUBSIDED, AND SCABS FORMED.

  Patient problems: Erythema; Fluid Discharge; Rash

  MAUDE report 19269474 ↗
• MalfunctionJul 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY OVARIECTOMY PROCEDURE, DURING MUSCLE CLOSURE, THE NEEDLE GOT LOOSE FROM THE STAND. IT WAS NOTED THAT THERE WAS NO EXTRA BLOOD LOSS. TO RESOLVE THE ISSUE, ANOTHER STRAND WAS TAKEN AND THE CLOSURE WAS MADE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278020 ↗
• MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON NOTICED THAT THE NEEDLE HAD BEEN REMOVED FROM THE THREAD. A SECOND DEVICE FROM THE SAME LOT AND THE SAME REFERENCE WAS ALSO USED DEFECTIVE. THE TEAM THEREFORE DECIDED TO PUT THE OFFENDING BOX ASIDE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640822 ↗
• MalfunctionApr 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE SUTURING A SINGLE KNOT, THE THREAD AND NEEDLE SEPARATED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167927 ↗
• MalfunctionFeb 9, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE BREAKS OFF FROM THE THREAD AFTER 2-3 STITCHES. THE ISSUE HAD ALSO BEEN SEEN WHEN THE THREAD IS TAKEN OUT OF THE PACKAGE.

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

  MAUDE report 13498665 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN SUBCUTANEOUS SUTURE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. OCCURRED 36 TIMES AS THE SURGEON TRIED ALL THE THREADS CONTAINED IN THE PACKAGING. ANOTHER DEVICE FROM DIFFERENT LOT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281591 ↗
• MalfunctionMay 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DISLODGED DURING ITS PASSAGE THROUGH THE SUBCUTANEOUS TISSUE AFTER SEVERAL POINTS MADE WITHOUT DIFFICULTY. THE NEEDLE WAS FOUND AND REMOVED USING A BRIGHTNESS AMPLIFIER.

  Patient problems: No Information

  MAUDE report 8627868 ↗

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