Polysorb CL-538Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521041042), received between May 2, 2023 and May 2, 2023 — classified as 4 injuries.

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.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN LUMBAR PROCEDURE, THE PATIENT RETURNED AFTER 5 TO 7 WEEKS WITH WOUND DEHISCENCE, THERE WOUND DID NOT HEAL PROPERLY OR SUTURE FRAGMENTS. THE SUTURE WERE USED ON CLOSURE OF LUMBAR IN FASCIA AND SKIN DURING THE INITIAL PROCEDURE. THE PATIENT HAD TO GO BACK TO THE OPERATING ROOM TO GET RE-STITCHED USING SUTURE FROM OTHER COMPANY.

  Patient problems: Impaired Healing; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16855677 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN LUMBAR PROCEDURE, THE PATIENT RETURNED AFTER 5 TO 7 WEEKS WITH WOUND DEHISCENCE, THERE WAS NO EVIDENCE OF WOUND HEALING OR SUTURE FRAGMENTS. THE SUTURE WERE USED ON CLOSURE OF LUMBAR IN FASCIA AND SKIN DURING THE INITIAL PROCEDURE. THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM TO GET RE-STITCHED USING SUTURE FROM DIFFERENT COMPANY.

  Patient problems: Impaired Healing; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16855208 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN LUMBAR PROCEDURE, THE PATIENT RETURNED AFTER 5 TO 7 WEEKS WITH WOUND DEHISCENCE, THERE WAS NO EVIDENCE OF PROPER WOUND HEALING OR SUTURE FRAGMENTS. THE SUTURE WERE USED ON CLOSURE OF LUMBAR IN FASCIA AND SKIN DURING THE INITIAL PROCEDURE. THE PATIENT HAD TO GO BACK TO THE OPERATING ROOM TO GET STITCHED UP AGAIN SUING A SUTURE FROM A DIFFERENT COMPANY.

  Patient problems: Impaired Healing; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16855174 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN LUMBAR PROCEDURE, THE PATIENT RETURNED AFTER 5 TO 7 WEEKS WITH WOUND DEHISCENCE, THERE WAS NO EVIDENCE OF WOUND HEALING OR SUTURE FRAGMENTS. THE SUTURE WERE USED ON CLOSURE OF LUMBAR IN FASCIA AND SKIN DURING THE INITIAL PROCEDURE. THE PATIENT HAD TO GO BACK TO THE OPERATING ROOM TO GET THE INCISION RECLOSED USING ANOTHER SUTURE FROM COMPETITOR.

  Patient problems: Impaired Healing; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16854879 ↗

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