Polysorb CL-9-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521044333), received between Apr 2, 2020 and Apr 1, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF KNEE REPLACEMENT SURGERY, WHILE PREPARING TO CLOSE THE INCISION, THE INNER PACKAGING OF THE SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS OPENED AND THE NEEDLE AND SUTURE WERE FOUND TO BE DETACHED. THE ORIGINALLY PURPLE SUTURE APPEARED GREENISH-BLUE AND CRUMBLED AT THE SLIGHTEST TOUCH. A STERILE DRAPE WAS IMMEDIATELY APPLIED, MEDICAL STAFF CHANGED TO NEW STERILE GLOVES, AND A COMPLIANT SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS OPENED TO PROCEED WITH CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758938 ↗
• MalfunctionOct 3, 2024Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A INGUINAL HERNIA SURGERY, WHEN SUTURING THE WOUND, THE SUTURE BROKE AND THE REMAINING SUTURE HAD POWDERING PHENOMENON, CAUSING THE PATIENT'S WOUND TO BLEED AND DID NOT STOP FOR A LONG TIME. ANOTHER BRAND OF SUTURE WAS USED TO RESOLVE THE ISSUE WHICH DELAYED THE SUTURING TREATMENT TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20360086 ↗
• MalfunctionJun 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A GENERAL SURGERY, BEFORE USE OF THE DEVICE, THE SUTURE BROKE WHEN IT WAS GENTLY PULLED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595424 ↗
• MalfunctionApr 15, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, WHEN THE PACKAGE WAS OPENED, THE SUTURE WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104732 ↗
• MalfunctionDec 18, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE BUT BEFORE USING IT ON THE PATIENT, WHEN PREPARING TO COUNT THE SYNTHETIC ABSORBABLE SURGICAL SUTURES, IT WAS DISCOVERED THAT ONE ORIGINALLY CONTAINED 5 SUTURES BUT NOW CONTAINED 6 SUTURES, WHICH DID NOT MATCH THE NUMBER IN THE OUTER PACKAGING. TO RESOLVE THE ISSUE, THE SUTURE WAS REPLACED WITH A NEW PACK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18349080 ↗
• MalfunctionDec 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, EXPLORATORY LAPAROTOMY, RADICAL SURGERY OF SIGMOID COLON CANCER WAS PERFORMED ON (B)(6) 2023. ABSORBABLE THREAD WAS USED TO SUTURE THE INCISION DURING THE OPERATION. ON (B)(6) 2023, WHEN THE INCISION DRESSING WAS CHANGED, IT WAS FOUND THAT THERE WAS REDNESS, SWELLING, EXUDATION, AND THIN PUS AT THE FOUR STITCHES IN THE MIDDLE OF THE ABDOMINAL WALL INCISION. THE SUTURE WAS REMOVED, AND THE SYMPTOMS DISAPPEARED AFTER DRESSING CHANGE AND DISINFECTION.

  Patient problems: Erythema; Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 18247902 ↗
• InjurySep 6, 2023Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO OPEN SPINE SURGERY, THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL DUE TO WOUND DEHISCENCE FROM CERVICAL SPINE TO UPPER THIRD OF THORACIC. THE PATIENT WAS RE-OPERATED TO CLOSE WOUND WITH SUTURE. HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 17692236 ↗
• MalfunctionMay 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROINTESTINAL PERFORATION REPAIR, THE NEEDLE AND THREAD OF THE SUTURES WERE EASILY DETACHED AND EASILY UNRAVELED. THE THREAD WAS PRONE TO BREAKAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THIS RESULTED TO INCREASED PATIENT DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 14290994 ↗
• MalfunctionApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE WAS FOUND DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9914955 ↗

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