Polysorb CLT-13-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521044517), received between Jul 15, 2022 and Jul 31, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY FOR SCOLIOSIS, WHEN THE SUTURE WAS USED IN THE DORSAL MUSCLE, FOR THE THREE SUTURES IN THE FIVE SUTURES THAT WERE IN THE PACKAGE, WHEN THE SCRUB NURSE ATTEMPTED TO GRASP THE NEEDLE, THE NEEDLE AND SUTURE DISCONNECTED CONSECUTIVELY IN THREE SUTURES. THE THREE SUTURES WERE NOT USED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431007 ↗
• MalfunctionJul 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CEREBRAL ANEURYSM CLIPPING, WHEN SEWING THE SUBCUTANEOUS TISSUE WHEN CLOSING THE HEAD, THE NURSE DISCOVERED THAT THE NEEDLE TIP WAS ON THE FLOOR BETWEEN THE INSTRUMENT TABLE AND THE OPERATING TABLE. THE DEVICE WAS REPLACED WITH A NEW ONE AND COMPLETE THE CASE WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065096 ↗
• MalfunctionJul 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CEREBRAL ANEURYSM CLIPPING, WHEN SEWING THE SUBCUTANEOUS TISSUE WHEN CLOSING THE HEAD, SEWED SUB SEQUENTLY, THE NURSE DISCOVERED THAT THE NEEDLE TIP WAS ON THE FLOOR BETWEEN THE INSTRUMENT TABLE AND THE OPERATING TABLE. THE DEVICE WAS REPLACED WITH A NEW ONE AND COMPLETED THE CASE WITH NO PATIENT INJURY. IT WAS HIGHLY POSSIBLE THAT THE TISSUE WAS BROKEN AFTER BEING SEWED BUT NO ONE WAS AWARE OF THE MOMENT IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033604 ↗

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