Polysorb CL-15-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521040243), received between Jun 3, 2021 and Jun 7, 2021 — classified as 5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 51 DAYS AFTER THE OPEN PROCEDURE, PALPABLE DEFECT ON SUPEROMEDIAL BORDER PATELLA WAS SEEN AND FELT. THE PATIENT WAS SENT FOR ULTRASOUND TO EVALUATION TENDON & FLUID SENT FOR ANALYSIS, RESULTS WERE PENDING. NO FURTHER SURGERY PLANNED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 11951899 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RIGHT TOTAL KNEE ARTHROPLASTY REVISION EIGHT MONTHS AGO. THE PATIENT COMPLAINED OF LEFT HIP PAIN AFTER FALLING ON THE THIRD MONTH AFTER THE SURGERY. X-RAYS AND MRI WERE PERFORMED AND THE RESULTS WERE NEGATIVE FOR FRACTURE AND CEREBROSPINAL INJURY LEFT BURSA. ON THE EIGHT MONTH POST SURGERY, THE PATIENT REPORTED INCREASED SWELLING, PAIN, AND PALPABLE DEFECT ON SUPEROMEDIAL. X-RAY WAS PERFORMED AND SHOWED SLIGHT LATERAL TILT. MRI RESULT IS PENDING. NO SURGERY PLANNED AT THIS TIME.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11946426 ↗
• InjuryJun 3, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 44 DAYS AFTER TOTAL KNEE ARTHROPLASTY, THE PATIENT FELT DEFECT ON SUPEROMEDIAL BORDER PATELLA, ASPIRATE SYNOVASURE WAS DONE AND THE RESULT CAME OUT NEGATIVE FOR INFECTION. 57 DAYS AFTER THE ORIGINAL PROCEDURE, THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL, THE SURGERY SITE WAS CHECKED AND NO SUTURE WAS SEEN. THE ORIGINAL ABSORBABLE SUTURE THAT WAS USED TO HOLD THE TENDON MAY HAD BROKEN BETWEEN 2-3 WEEKS POST-OPERATIVELY AS PT REGIMEN BEGUN TO INCREASE. A NON-ABSORBABLE SUTURE WAS USED TO RESOLVE THE ISSUE, BUT THE SUTURE BROKE DURING HAND TYING. A PRODUCT FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11935592 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 44 DAYS POSTOPERATIVE TO RIGHT TOTAL KNEE ARTHROSCOPY, A FLUID WAS DISCOVERED ABOVE PALPABLE DEFECT SUPEROMEDIAL BORDER PATELLA. RE-OPERATION WAS PERFORMED 58 DAYS POSTOPERATIVE TO REPAIR PALPABLE DEFECT IN CAPSULE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11931098 ↗
• InjuryJun 3, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN OPEN TOTAL KNEE ARTHROPLASTY, ON CLOSING THE JOINT CAPSULE, THE KNEE WAS POPPING OUT, LATERAL TILT PATELLA, PALPABLE DEFECT SUPEROMEDIAL BORDER PATELLA, 1ST CASE WAS NOT SUSPECTING SUTURE, HAD SLIGHT RESIDUAL VALGUS. THE PATIENT WAS TAKEN BACK FOR REOPERATION TO RESOLVE THE ISSUE AND NO SUTURE WAS SEEN AND THERE WAS A NOTED ROTATION OF COMPONENTS. THE PROCEDURE WAS COMPLETED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement; Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 11930011 ↗

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