Polysorb CL-869Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521042698), received between Aug 8, 2021 and May 5, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING THE OPEN CERVICAL FUSION, THE PATIENT EXPERIENCED WOUND DEHISCENCE AND SENSITIVITY USING THE TWO SUTURES.

  Patient problems: Local Reaction; Wound Dehiscence

  MAUDE report 16876546 ↗
• MalfunctionMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE OPEN CERVICAL PROCEDURE, THE PATIENT PRESENTED AT 10 DAYS FOR STAPLE REMOVAL, SKIN IRRITATION WAS NOTED.

  Patient problems: Inflammation

  MAUDE report 16857661 ↗
• 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 16856598 ↗
• 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 16856525 ↗
• 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, THE 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 16856455 ↗
• 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 16854941 ↗
• MalfunctionApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN PROCEDURE, THE SUTURE WAS CAUSING DEHISCENCE.

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 16808996 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A PROCEDURE, THE PATIENT CAME BACK FOR IRRIGATION AND DEBRIDEMENT DUE TO ABSCESS FROM THE SUTURE.

  Patient problems: Abscess

  MAUDE report 12937516 ↗
• MalfunctionAug 8, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SUTURING THE DERMIS, AS THE SCRUB NURSE OPENED THE PACKET, THE NEEDLE WAS NOT STUCK IN THE SPONGE AND FELL OUT. INSTEAD, IT WAS FOUND THAT THE NEEDLE FELL IN THE PACKET. A NEW PRODUCT WAS TAKEN OUT AND THE OPERATION WAS COMPLETED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292106 ↗

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