Polysorb CL-965Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521043794), received between Apr 26, 2017 and Jun 27, 2018 — 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.

• MalfunctionJun 27, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE AND SUTURE BROKE. THEY OPENED A NEW ONE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643705 ↗
• MalfunctionApr 26, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE THE NEEDLE BROKE OFF THE SUTURE. NEW SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE, NO HARM TO PATIENT PATIENT STATUS- NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525024 ↗

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