Polysorb CL-2MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521040465), received between Sep 4, 2020 and Feb 6, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryFeb 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TRANSABDOMINAL HYSTERECTOMY, THE SUTURE WAS DISCOVERED TO HAVE A BROKEN TIP. THE TIP WAS NEVER FOUND AND THE BROKEN PORTION OF THE NEEDLE WOULD HAVE BEEN 1MM OR LESS. A MANUAL SWEEP WAS PERFORMED AND AN X-RAY WAS DONE AND IT DID NOT REVEAL ANY UNSPECIFIED FOREIGN OBJECT. TO RESOLVE THE ISSUE, SAME TYPE AND SIZE OF THE SUTURE WAS USED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 16305585 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN ANTERIOR CRUCIATE LIGAMENT REPAIR, THE PATIENT HAD SWELLING, CELLULITIS AND BACTERIAL WOUND INFECTION OF ESCHERICHIA COLI, STAPHYLOCOCCUS AUREUS AND ENTEROCOCCUS FAECALIS AT THE INCISION SITE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Bacterial Infection; Cellulitis; Post Operative Wound Infection; Swelling

  MAUDE report 10495008 ↗

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