Polysorb CL-883Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521042773), received between Oct 30, 2018 and Jul 18, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionJul 18, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VAGINAL PROCEDURE, DURING THREAD PASSAGE THROUGH TISSUE, THE THREAD BROKE. THE SURGICAL TIME WAS EXTENDED BY 2 MINUTES. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347680 ↗
• MalfunctionApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC MYOMECTOMY, TWO SUTURES HAD ISSUES. THE FIRST SUTURE HAD AN INCORRECT NEEDLE QUANTITY; THERE WERE ONLY 4 INSTEAD OF 5. WHILE FOR THE SECOND SUTURE, THE NEEDLE DISENGAGED AND FELL INTO PATIENT'S CAVITY AND WAS REMOVED AT THE SAME TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693640 ↗
• MalfunctionOct 30, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN STITCHING THE SKIN TO CLOSE THE WOUND ON AN OPEN PROCEDURE, THE THREAD BROKE. THE PHYSICIAN USED ANOTHER NEW SAME TYPE OF DEVICE TO COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018989 ↗

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