Polysorb CL-526Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521040915), received between Mar 4, 2020 and Jun 21, 2021 — 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.

• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUBCUTANEOUS TISSUE CLOSURE ON AN OPEN LAMINECTOMY, TOWARDS THE END OF THE PROCEDURE, THE NEEDLE GOT SEPARATED FROM THE THREAD ALMOST THREE TIMES WHILE USING A CONTINUOUS SUTURING TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037912 ↗
• MalfunctionAug 7, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING DURING AN OPEN PROCEDURE, THE NEEDLE OF THE DEVICE BROKE. SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381296 ↗
• MalfunctionMar 4, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE THREADS WERE BROKE WHEN PASSING THROUGH THE TISSUE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9785890 ↗

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