Polysorb L-73Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521046894), received between Aug 2, 2017 and May 8, 2020 — 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.

• MalfunctionMay 8, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TWO THREADS BROKE UPON REMOVING FROM THE BLISTER. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10039501 ↗
• MalfunctionOct 24, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD WAS BROKEN INTO PIECES IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973634 ↗
• MalfunctionAug 2, 2017Degraded; Degraded

  ACCORDING TO THE REPORTER, WHEN THE USER ATTEMPTED TO USE THE PRODUCT DURING THE PROCEDURE, THE THREAD WAS DETERIORATED AND IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR THE PATIENT. THE STATUS OF THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6761109 ↗

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