Polysorb CL-830Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521042087), received between Aug 15, 2018 and Jun 24, 2024 — classified as 10 injuries, 1 malfunction.

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

• InjuryJun 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19595980 ↗
• InjuryJun 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19595944 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF 4 SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19590356 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF 4 SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19590130 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF 4 SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19589891 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A TOTAL RIGHT KNEE PROCEDURE, FOUR BRAIDED POLYESTER SUTURES UNRAVELED DURING THE JOINT CAPSULE CLOSURE AND SKIN CLOSURE. EIGHT OTHER SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED INSTRUMENT TIES STITCHING TECHNIQUE. POST-OPERATIVELY, THE PATIENT CAME BACK WITH WOUND DEHISCENCE. THE PATIENT WAS SCHEDULED TO RETURN FOR ANOTHER OPERATION TO DEBRIDE AND CLOSE THE WOUND.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19571031 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A TOTAL RIGHT KNEE PROCEDURE, FOUR BRAIDED POLYESTER SUTURES UNRAVELED DURING THE JOINT CAPSULE CLOSURE AND SKIN CLOSURE. EIGHT OTHER SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED INSTRUMENT TIES STITCHING TECHNIQUE. POST-OPERATIVELY, THE PATIENT CAME BACK WITH WOUND DEHISCENCE. THE PATIENT WAS SCHEDULED TO RETURN FOR ANOTHER OPERATION TO DEBRIDE AND CLOSE THE WOUND.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19571016 ↗
• MalfunctionApr 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE CAME OFF FROM THE THREAD ON BOTH SUTURING DEVICES.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9989694 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER GENERAL WOUND CLOSURES ON HIP AND KNEE PROCEDURES, THE PATIENT DEVELOPED A HYPER INFLAMMATORY RESPONSE OR REDNESS OF THE SKIN. FOLIC TREATMENT WAS USED TO TREAT THE INFLAMMATORY CONDITION OF THE PATIENT.

  Patient problems: Inflammation

  MAUDE report 9824284 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN ORTHOPEDIC PROCEDURE, THE PATIENT DEVELOPED A SKIN ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9619524 ↗
• InjuryAug 15, 2018Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING BILATERAL BRACHIOPLASTY, ON CLOSURE OF FASCIA AND SKIN, THE KNOTS KEPT UNRAVELING OR THE SUTURE KEPT BREAKING AND THAT IT ADDED CLOSE TO AN HOUR OF OPERATING TIME. THEY OPENED ANOTHER SUTURE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7786854 ↗

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