Polysorb CL-22-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521040342), received between Dec 5, 2019 and May 19, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 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.

• MalfunctionMay 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRAUMATOLOGY ORTHOPEDIC PLATE FIXATION (FASCIA SUTURE), THE SUTURE BROKE.

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

  MAUDE report 22044190 ↗
• MalfunctionJun 14, 2024Break; Product Quality Problem; Device Slipped; Break; Product Quality Problem; Device Slipped

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE BEFORE THE SURGEON TIED THE KNOT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19538959 ↗
• 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 9569756 ↗
• 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 9547112 ↗
• InjuryDec 6, 2019Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE HEMILAMINECTOMY, THE PATIENT HAD FEVER, DRAINAGE, AND WAS POSITIVE FOR STAPHYLOCOCCUS.

  Patient problems: Fever; Staphylococcus Aureus; Wound Dehiscence

  MAUDE report 9421240 ↗
• 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 9416749 ↗

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