Polysorb L-1785KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521046306), received between Sep 13, 2017 and Mar 29, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 29, 2018Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO AN OPEN PROCEDURE STRABISMUS SURGERY, THE SUTURE WAS BROKEN. THEY REPLACED IT WITH A SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381722 ↗
• MalfunctionNov 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A STRABISMUS SURGERY, TWO OF THE DEVICE¿S SUTURE BROKE. NO PART OF THE DEVICE FELL INTO THE PATIENT. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037622 ↗
• MalfunctionSep 13, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPTHALMIC SURGERY, WHILE ON SUTURING THE SOFT TISSUES OF THE EYEBALL, THE DEVICE¿S THREAD BROKE. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6862245 ↗

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