Polysorb CL-906Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521043282), received between May 9, 2019 and May 20, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionMay 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 19356466 ↗
• MalfunctionFeb 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN SUTURING THE TISSUE, THE NEEDLE OF THE SIX SUTURES BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385460 ↗
• InjuryDec 26, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, WHILE SUTURING THE UTERUS, THE SURGEON THOUGHT THAT THE NEEDLE WAS BLUNT, HOWEVER ON CLOSE INSPECTION THE TIP WAS MISSING. AN ON-CALL CONSULTANT WAS CALLED IN AND PERFORMED AN ABDOMINAL AND PELVIC X-RAY TO MAKE SURE THAT THE TIP HAD NOT FALLEN INTO BODY, WHICH WAS NOT FOUND. SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO THE PRODUCT CONDITION. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended

  MAUDE report 9519660 ↗
• InjuryDec 22, 2019Break; Break

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF A CESAREAN SECTION, THE TIP OF THE SUTURE NEEDLE WAS NOTED TO BE MISSING. ABDOMINAL X-RAY WAS PERFORMED ON THE TABLE PRE-CLOSURE AND NO TIP WAS VISUALIZED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9508715 ↗
• InjuryMay 9, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE CLOSING THE SECOND LAYER OF THE UTERUS DURING CESAREAN SECTION, THE NEEDLE FELT BLUNT AS THE SURGEON WAS COMING TOWARDS THE END OF THE SECOND LAYER. IT WAS NOTICED THAT THE TIP WAS MISSING, THEY HAD TO PERFORM 2 X-RAYS TO SEE IF THEY COULD LOCATE THE TIP OF THE NEEDLE, BUT THEY WERE UNABLE TO IDENTIFY AND AS SUCH HAVE ORDERED A PATIENT MRI TO BE PERFORMED AFTER THE 48 HOURS AS RECOMMENDED BY CONSULTANT RADIOLOGIST. THE INCIDENCE RESULTED IN THE PATIENT HAVING A PROLONGED PERIOD OF 4 HOURS WHERE THE ABDOMEN WAS OPEN AND REQUIRED CONTINUOUS ANALGESIA. POST OPERATIVELY THE PATIENT HAD PYREXIA AND AS SUCH HAS BEEN TREATED FOR SEPSIS.

  Patient problems: Fever; Foreign Body In Patient; No Code Available; Radiation Exposure, Unintended; Sepsis

  MAUDE report 8597598 ↗

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