Polysorb CL-20-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521040298), received between Oct 15, 2019 and Feb 17, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRAUMA SURGERY FASCIA, BOTH NEEDLE AND THREAD BROKE IMMEDIATELY WHILE PERFORMING AN INTERRUPTED SUTURING TECHNIQUE. THE SAME ISSUE OCCURRED ON ALL FIVE SUTURES FROM THE SAME BOX. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363428 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRAUMA SURGERY FASCIA, BOTH NEEDLE AND THREAD BROKE IMMEDIATELY WHILE PERFORMING AN INTERRUPTED SUTURING TECHNIQUE. THE SAME ISSUE OCCURRED ON ALL FIVE SUTURES FROM THE SAME BOX. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363427 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRAUMA SURGERY FASCIA, BOTH NEEDLE AND THREAD BROKE IMMEDIATELY WHILE PERFORMING AN INTERRUPTED SUTURING TECHNIQUE. THE SAME ISSUE OCCURRED ON ALL FIVE SUTURES FROM THE SAME BOX. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363358 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRAUMA SURGERY FASCIA, BOTH NEEDLE AND THREAD BROKE IMMEDIATELY WHILE PERFORMING AN INTERRUPTED SUTURING TECHNIQUE. THE SAME ISSUE OCCURRED ON AL FIVE SUTURES FROM THE SAME BOX. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251443 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRAUMA SURGERY FASCIA, BOTH NEEDLE AND THREAD BROKE IMMEDIATELY WHILE PERFORMING AN INTERRUPTED SUTURING TECHNIQUE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251353 ↗
• InjuryJan 9, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER A LAMINECTOMY LUMBAR DECOMPRESSION PROCEDURE, THE PATIENT DEVELOPED WOUND DEHISCENCE. WOUND VACUUM PLACEMENT WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 9569621 ↗
• InjuryJan 9, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER A LAMINECTOMY LUMBAR DECOMPRESSION PROCEDURE, THE PATIENT DEVELOPED WOUND DEHISCENCE. WOUND VACUUM PLACEMENT WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 9569594 ↗
• InjuryJan 3, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE REPLACEMENT ARTHROPLASTY, THE PATIENT PRESENTED WITH DEHISCENCE ON LEFT KNEE FOL LOWING A FALL. INCISION AND DRAINAGE WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9547051 ↗
• InjuryDec 5, 2019Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE OPEN LAMINECTOMY LUMBAR DISK FORAMEN FACET, THE PATIENT EXPERIENCED DEHISCENCE.

  Patient problems: Fever; Staphylococcus Aureus; Wound Dehiscence

  MAUDE report 9420699 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE NEUROLOGY OPEN PROCEDURE, THE PATIENT HAD WOUND ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9415629 ↗
• MalfunctionOct 15, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING LIVER TRANSPLANT PROCEDURE. WHEN THE SURGEON ABOUT TO USED THE SUTURING DEVICE TO CLOSE THE WOUND, THE NURSE REMOVED TWO BOARDS OF SUTURES PACKED WITH FIVE NEEDLES, HOWEVER SIX NEEDLES APPEARED WHEN ONE BOARD WAS OPENED AND COUNTED. THEY TRIED TO RE COUNT THE NEEDLE AND SIX NEEDLES WAS CONFIRMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191869 ↗

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