Polysorb SL-5640Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521048652), received between Feb 20, 2018 and May 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 14, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO USE, NEEDLE WAS NOT VISIBLE IN THE NEEDLE HOLDER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315295 ↗
• MalfunctionFeb 28, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN SUTURING DURING AN OPEN PROCEDURE, A VERY SMALL SPECK OF THE NEEDLE CAME OFF. THERE WAS NO X-RAY NEEDED. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377649 ↗
• MalfunctionFeb 20, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD PACKAGING ISSUE. THERE WAS ADDITIONAL NEEDLE FOUND IN THE PACKAGING THAT WAS NOT MEANT TO BE IN THE PACKET. MOVED THE PACKET TO ONE SIDE AND PLACED THE ADDITIONAL NEEDLE IN THE NEEDLE HOLDER FOR TIME BEING THEN WILL BE PACKED AFTER FOR RETURN. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7282763 ↗

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