Polysorb CL-964Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521043787), received between Jan 2, 2020 and Jun 25, 2024 — classified as 11 injuries.

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. How this data works · Data updated Oct 13, 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 25, 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 19610214 ↗
• InjuryJun 25, 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 19610210 ↗
• 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 19590352 ↗
• 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 19590345 ↗
• 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 19590085 ↗
• 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 19571008 ↗
• 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 19570998 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A KNEE-REVISION PROCEDURE, THE PATIENT PRESENTED WITH SKIN BLISTERING AND PROTEUS MIRABILIS INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 9569191 ↗
• InjuryJan 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE AN ANKLE FRACTURE OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE, THE PATIENT PRESENTED WITH WOUND DEHISCENCE WITH RETAINED HARDWARE. IT WAS NOTED THAT THREE SUTURING DEVICES WERE USED. WOUND VACUUM PLACEMENT WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 9567250 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPEN INTRAMEDULLARY NAILING OF TIBIA, THE PATIENT EXPERIENCED CELLULITIS.

  Patient problems: Cellulitis

  MAUDE report 9546489 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER USING FOUR DIFFERENT SUTURES IN AN ANKLE OPEN REDUCTION INTERNAL FIXATION, THERE WERE WOUND DEHISCENCE WITH RETAINED HARDWARE OF THE DISTAL FEMUR, RIGHT ANKLE. AN ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Post Operative Wound Infection

  MAUDE report 9538281 ↗

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