Polysorb L-113Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521045798), received between Aug 27, 2018 and Dec 27, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A SPINAL PROCEDURE, AFTER OPENING THE PACKAGE, THE SUTURE BROKE. THE EVENT OCCURRED DURING THE PROCEDURE BUT WAS NOT USED TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199265 ↗
• MalfunctionDec 17, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURES WERE DEFECTIVE AND BROKEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8168916 ↗
• MalfunctionOct 18, 2018Break; Break

  ACCORDING TO THE REPORTER, THE THREAD OF THE DEVICE BROKE. WHEN THE THREAD OF SUTURE IS TOUCHED, IT IS EASY TO BREAK. IT WAS A ISOLATE CASE. THEY REPLACE THE DEVICE TO BE ABLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7980463 ↗
• MalfunctionAug 27, 2018Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A WEDGE SEGMENTAL RESECTION, THE ACCOUNT FOUND THAT THERE WERE VARIATION IN THE COLOR OF THE SUTURE, ALSO THE THREAD BROKE EASILY. THEY USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7818812 ↗

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