Polysorb CL-86-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521042605), received between Mar 15, 2019 and Aug 11, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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 10 most recent of 10 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 A CRANIOTOMY TUMOR WITH NAVIGATION, 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 17513245 ↗
• InjuryAug 11, 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 17511117 ↗
• InjuryAug 11, 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 17507026 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A 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 17506281 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A CRANIOPLASTY, 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 17503270 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A REVISION THORACOLUMBAR 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 17500065 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A CRANIOTOMY TUMOR WITH NAVIGATION, 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 17500041 ↗
• 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 17499568 ↗
• InjuryJul 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO AN OPEN SPINAL CLOSURES (LAMINECTOMY AND SPINAL FUSIONS), THE SUTURE SEEMED TO DISSOLVE WITHIN A FEW WEEKS AND WAS BREAKING DOWN BEFORE EXPECTED, WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence; Wound Infection

  MAUDE report 17266857 ↗
• MalfunctionMar 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A FEMORAL POPLITEAL PROCEDURE, WHILE THE SURGEON WAS SUTURING AROUND CLOSING THE PATIENT AND PASSED THROUGH TISSUE, THE NEEDLE BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425324 ↗

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