Polysorb CL-13-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521040229), received between Sep 12, 2019 and Oct 19, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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.

• InjuryOct 19, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT 4 TO 5 WEEKS FOLLOWING AN OPEN TOTAL KNEE ARTHROPLASTY WHERE THREE SUTURES WERE USED, DEHISCENCE OF ALL TISSUE LAYERS THAT WERE SUTURED OCCURRED AFTER A FALL. ADDITIONAL SURGERY WAS REQUIRED AS AN INTERVENTION. IT WAS NOTED THAT THE SURGEON USED ANOTHER SUTURE FROM ANOTHER COMPANY.

  Patient problems: Wound Dehiscence

  MAUDE report 23334086 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, DEHISCENCE OF ALL TISSUE LAYERS EXCEPT THE FASCIA OCCURRED POST-OPERATIVELY. THIS RAISES CONCERNS ABOUT THE DEVICE'S STRENGTH AT FOUR WEEKS COMPARED TO OTHER MANUFACTURING SUTURES. TWO SUTURES WERE USED, WHILE THE FASCIA WAS CLOSED WITH A DIFFERENT TYPE OF SUTURE. THE DEHISCENCE WAS ATTRIBUTED TO A FALL EXPERIENCED BY THE PATIENT AFTER SURGERY. ADDITIONAL SURGERY WAS REQUIRED, AND AN OPEN PROCEDURE WAS PERFORMED TO ADDRESS THE DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 23285652 ↗
• MalfunctionFeb 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE SUTURE WAS COMING APART AFTER A WEEK OR TWO.

  Patient problems: Insufficient Information

  MAUDE report 21314691 ↗
• 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 17506958 ↗
• MalfunctionDec 18, 2019Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING OPEN SPINAL LAMINECTOMY, THE SUTURE WOULD NOT SLIDE DOWN TO THE TISSUE. SURGEONS HAD TO CUT OUT MULTIPLE SUTURES AND RE-SUTURED WITH ANOTHER PRODUCT. IN ADDITION, THE NEEDLES WERE BENDING DURING SKIN CLOSURE WHILE USING INTERRUPTED SUTURE TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489555 ↗
• MalfunctionSep 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL KNEE REPLACEMENT, WHILE THE SURGEON IS PERFORMING BASIC PASSING SUTURING TECHNIQUE THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9017394 ↗

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