Polysorb L-2752KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521046559), received between Jul 6, 2017 and Feb 15, 2021 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionFeb 15, 2021Break; Break

  ACCORDING TO THE REPORTER, ON AN OPHTHALMOLOGICAL PROCEDURE, THE SUTURE BROKE QUICKLY AND BECAME LINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327229 ↗
• InjuryJul 6, 2017Break; Dull, Blunt; Break; Dull, Blunt

  ACCORDING TO THE REPORTER, DURING A SQUINT PROCEDURE THE USED DEVICE NEEDLE BROKE. WHEN USING THE DEVICE TO SUTURE THE CONJUNCTIVA AND THE SURROUNDING MUSCLES, THE NEEDLE DID NOT PASS THROUGH THE TISSUE EASILY AND THE SURGEON HAD TO USE FORCE TO PASS THE POINT OF THE NEEDLE. THIS ISSUE OCCURRED WITH 5 SUTURES EACH FROM 2 DIFFERENT LOTS (TOTAL OF 10 SUTURES). THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES AND THERE WAS TISSUE DAMAGE AND LOSS AS A RESULT OF THIS COMPLAINT. THE EXTENT OF THE TISSUE DAMAGE AND LOSS WILL NOT BE MADE AVAILABLE. NO ADDITIONAL OPERATION WILL BE NEEDED. THE PATIENT STATUS IS LISTED AS ALIVE WITH NO INJURY.

  Patient problems: Tissue Damage

  MAUDE report 6689218 ↗
• InjuryJul 6, 2017Break; Dull, Blunt; Break; Dull, Blunt

  ACCORDING TO THE REPORTER, DURING A SQUINT PROCEDURE THE USED DEVICE NEEDLE BROKE. WHEN USING THE DEVICE TO SUTURE THE CONJUNCTIVA AND THE SURROUNDING MUSCLES, THE NEEDLE DID NOT PASS THROUGH THE TISSUE EASILY AND THE SURGEON HAD TO USE FORCE TO PASS THE POINT OF THE NEEDLE. THIS ISSUE OCCURRED WITH 5 SUTURES EACH FROM 2 DIFFERENT LOTS (TOTAL OF 10 SUTURES). THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES AND THERE WAS TISSUE DAMAGE AND LOSS AS A RESULT OF THIS COMPLAINT. THE EXTENT OF THE TISSUE DAMAGE AND LOSS WILL NOT BE MADE AVAILABLE. NO ADDITIONAL OPERATION WILL BE NEEDED. THE PATIENT STATUS IS LISTED AS ALIVE WITH NO INJURY.

  Patient problems: Tissue Damage

  MAUDE report 6689193 ↗

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