Polysorb CL-14-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521040236), received between Aug 1, 2022 and Aug 11, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO AN OPEN POSTERIOR SPINAL FUSION, THE SUTURE SEEM TO DISSOLVE WITHIN A FEW WEEKS AND BREAKING DOWN BEFORE EXPECTED, WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION. AS A RESPONSE TO THE SITUATION, INCISION AND DRAINAGE PROCEDURES WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17507007 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR MICRODISCECTOMY, THE SUTURE SEEM TO DISSOLVE WITHIN A FEW WEEKS AND BREAKING DOWN BEFORE EXPECTED, WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION. AS A RESPONSE TO THE SITUATION, INCISION AND DRAINAGE PROCEDURES WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17502756 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR DECOMPRESSION LAMINECTOMY, THE SUTURE SEEMED TO DISSOLVE WITHIN A FEW WEEKS AND WAS BREAKING DOWN BEFORE EXPECTED WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION. AS A RESPONSE TO THE SITUATION, INCISION AND DRAINAGE PROCEDURES WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17499986 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR MICRODISCECTOMY, THE SUTURE SEEM TO DISSOLVE WITHIN A FEW WEEKS AND BREAKING DOWN BEFORE EXPECTED, WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION. AS A RESPONSE TO THE SITUATION, INCISION AND DRAINAGE PROCEDURES WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17499713 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR DECOMPRESSION LAMINECTOMY, THE SUTURE SEEM TO DISSOLVE WITHIN A FEW WEEKS AND BREAKING DOWN BEFORE EXPECTED, WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION. AS A RESPONSE TO THE SITUATION, INCISION AND DRAINAGE PROCEDURES WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17499582 ↗
• MalfunctionAug 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE OF THE TWO SUTURES EASILY DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO CONTINUE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 15138618 ↗

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