Polysorb CL-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521040090), received between Sep 11, 2023 and Jan 24, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN LESION EXCISION AND PEDICLE FLAP TRANSPLANTATION WHEN THE SURGEON OPENED THE ABSORBABLE SUTURE AND GENTLY PULLED BY HAND, THE SUTURE BROKE AND COULD NOT BE USED. AS A RESOLUTION THE CIRCULATING NURSE IMMEDIATELY REPLACED WITH ANOTHER BOX OF NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231588 ↗
• MalfunctionSep 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUPERFICIAL TUMOR RESECTION ON THE LEFT SHOULDER, WHEN SUTURING TO THE THIRD STITCH AND PASSING THROUGH THE SUBCUTANEOUS, THE SUTURING NEEDLE BROKE UNDER THE SKIN. THE INCISION WAS EXTENDED BY 1.25CM, THE WOUND WAS EXPLORED AND BROKEN NEEDLE WAS REMOVED. A NEW SUTURE WAS USED TO CLOSE THE WOUND. SURGICAL TIME WAS EXTENDED BY 25 MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17723995 ↗

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