Polysorb CL-239Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521040366), received between Apr 16, 2020 and Dec 3, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL KNEE JOINT REPLACEMENT, THE THREAD DISENGAGED FROM THE NEEDLE ON MULTIPLE FOILS WHEN PULLING THE SUTURE THROUGH ON THE FIRST PASS OF SUTURE WHEN CLOSING THE SUBCUTANEOUS TISSUE. A NEW BOX OF SUTURE WAS OPENED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938610 ↗
• MalfunctionOct 5, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE. ADDITIONAL SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10626008 ↗
• MalfunctionAug 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE ON THE ELBOW, ON CLOSING THE SUBCUTANEOUS LAYER OF THE SKIN, TWO SUTURE FOILS WERE OPENED AND BOTH DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10472141 ↗
• MalfunctionAug 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN CLOSING THE SUBCUTANEOUS LATER OF THE SKIN ON AN OPEN TOTAL HIP REPLACEMENT, THREE FOILS WERE OPENED AND IN ALL THREE FOILS, THE SUTURE DETACHED FROM THE NEEDLE IN THE FIRST PASS OF THE SUTURE INTO THE TISSUE. ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10470568 ↗
• MalfunctionAug 11, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL KNEE JOINT REPLACEMENT, THE SUTURE BROKE AND THE NEEDLE DISENGAGED FROM THE THREAD ON MULTIPLE FOILS WHEN PULLING THE SUTURE THROUGH ON THE FIRST PASS OF SUTURE WHEN CLOSING THE SUBCUTANEOUS TISSUE. A NEW BOX OF SUTURE WAS OPENED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10393087 ↗
• MalfunctionJun 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CONTINUOUS FASCIA CLOSURE ON AN OPEN CAESAREAN SECTION, THE NEEDLE CAME LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10175661 ↗
• MalfunctionApr 16, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A SUTURE THREAD BROKE.

  Patient problems: No Information

  MAUDE report 9966169 ↗

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