Polysorb CL-30-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521040489), received between Jan 10, 2024 and Aug 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT HAD A KNEE REVISION ON (B)(6) 2025, AFTER 28 DAYS, THE SUTURE HAD PREMATURE ABSORPTION. THE PATIENT HAD A SYSTEMIC INFECTION ON THE WOUND, INFLAMMATION, PAIN, AND REDNESS. THE PATIENT WAS READMITTED TO THE HOSPITAL AND HAD A REVISION ON (B)(6) 2025 TO EXPLANT THE SUTURE. DURING REVISION, IT WAS FOUND THAT THERE WAS NO SUTURE OR SUTURE REMNANTS.

  Patient problems: Inflammation; Pain; Tissue Breakdown; Unspecified Infection

  MAUDE report 22917739 ↗
• InjuryJan 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT EXPERIENCED CERVICAL FASCIAL DEHISCENCE. THE FASCIA WAS SEPARATING. THE SUTURE WAS OBSERVED TO BE FRIABLE AND DISSOLVED WITH KNOTS STILL PRESENT AND FASCIA/MUSCLE APPEARING HEALTHY END SEPARATED. THE PATIENT HAD FEW REMAINING SUTURES PRESENT. THE ISSUE ALSO RESULTED TO HOSPITALIZATION. THE PATIENT NEEDS A SEPARATE PROCEDURE TO ADDRESS THE DEHISCENCE THAT IS YET TO BE SCHEDULED.

  Patient problems: Wound Dehiscence

  MAUDE report 18488505 ↗

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