Polysorb CL-200-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521040274), received between Jun 22, 2018 and Jun 22, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ACCORDING TO THE REPORTER, THE SURGEON PERFORMED AN SKIN CLOSURE ON A SPINE PROCEDURE, AFTER 28 DAYS, WOUND DEHISCENCE WAS FOUND AND THERE WAS NO PRESENCE OF SUTURE LEFT ON THE WOUND. TO RESOLVE THE ISSUE, RECLOSURE OF THE OPEN WOUND WAS DONE. THE PATIENT ALSO RECEIVE ANTIBIOTIC THERAPY.

  Patient problems: Wound Dehiscence

  MAUDE report 7628963 ↗

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