Polysorb SL-5637Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521048621), received between May 17, 2018 and Mar 11, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PERINEAL REPAIR, THE NEEDLE DETACHED FROM THE SUTURE THREAD. A NEW PACKAGE OF SUTURE WAS IMMEDIATELY OPENED AND USED TO COMPLETE THE REPAIR, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567176 ↗
• MalfunctionNov 17, 2025Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING A C-SECTION (CESAREAN SECTION), WHILE CLOSING THE C-SECTION SCAR, THE SURGEON TIED THE KNOT AT THE BEGINNING OF MY RUNNING CLOSING SUTURE WITH NO ISSUES. THE KNOT STAYED TIED AND AFTER RUNNING THE WHOLE C-SECTION INCISION WITH NO ISSUES. AFTER TYING THE KNOT AT THE END OF THE INCISION, WITH 6 TO 8 KNOTS, THE SURGEON CUT THE FREE STRING AND THEN PULLED THE SUTURE THROUGH THE SKIN TO BURY THE KNOT. THE KNOTS WERE FINE UNTIL THE SURGEON WASHED THE PATIENT TO PUT THE ADHESIVE BANDAGES ON. THE SURGEON NOTICED THE END OF THE INCISION OPENED AND THE KNOT WAS UNRAVELED SO THE SURGEON HAD TO CLOSE IT AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568982 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DENTAL PROCEDURE, WHEN OPENING THE SUTURE BLISTER, THE THREAD WAS NOT CRIMPED ON THE NEEDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047487 ↗
• MalfunctionFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUTURE SEPARATED FROM THE NEEDLE UPON REMOVAL FROM PACKAGING. AN ADDITIONAL NEW SUTURE FROM THE SAME LOT WITHOUT ISSUE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401848 ↗
• MalfunctionOct 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTOPEXY PROCEDURE, A FEW MINUTES AFTER OPENING THE PACKAGE, THE DEVICE WAS BEING USED TO SUTURE THE ADIPOSE TISSUE VIA CROSS-STITCH TECHNIQUE WHEN THE THREAD BROKE. THIS WAS OBSERVED ON THREE SUTURES. A NEW SUTURE WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632148 ↗
• MalfunctionOct 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTOPEXY PROCEDURE, A FEW MINUTES AFTER OPENING THE PACKAGE, THE DEVICE WAS BEING USED TO SUTURE THE ADIPOSE TISSUE VIA CROSS-STITCH TECHNIQUE WHEN THE THREAD BROKE. THIS WAS OBSERVED ON THREE SUTURES. A NEW SUTURE WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632121 ↗
• MalfunctionMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE PROCEDURE, WHILE SUTURING, NEEDLE POPPED OFF FROM THE SWAGE. A NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664715 ↗
• MalfunctionNov 17, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE SURGERY, WHILE CLOSING THE SUBCUTICULAR LAYER, THE NEEDLE BROKE AT THE TIP, BUT DID NOT FALL INTO PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833651 ↗
• MalfunctionSep 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP REPLACEMENT PROCEDURE, THE NEEDLE BROKE IN HALF WHILE SUTURING THE SUBCUTICULAR TISSUE. IT WAS ALSO NOTED THAT PART OF THE NEEDLE FELL INTO THE INCISION, BUT IT WAS RECOVERED SUCCESSFULLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551042 ↗
• MalfunctionSep 23, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT PROCEDURE, WHEN THE SURGEON CLOSING THE SKIN LAYER, THE DEVICE'S NEEDLE BROKE IN HALF. THE SURGEON THEN USED ANOTHER DEVICE 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 12523916 ↗
• MalfunctionSep 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST PROCEDURE, NEEDLE POPPED OFF STRAND. ANOTHER STRAND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419225 ↗
• InjuryMar 29, 2021Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOUR WEEKS POST-MASTECTOMY AND BREAST REDUCTION, THE PATIENT EXPERIENCED SUTURE LINE SWELLING AND EXHIBITED DEHISCENCE. THE SUTURE WAS REMOVED TO RESOLVE THE ISSUE.

  Patient problems: Swelling/ Edema; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11582866 ↗
• MalfunctionDec 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BREAST IMPLANT EXCHANGE, THE THREAD SEPARATED FROM THE NEEDLE. ANOTHER DEVICE WAS USED 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 11086816 ↗
• MalfunctionDec 8, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, ON A LAPAROSCOPIC CHOLECYSTECTOMY AND BREAST EXCISION, THE THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964697 ↗
• MalfunctionJun 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MASTECTOMY, UPON CLOSING SKIN, THREE OF THE SAME SUTURES BROKE FROM THE STRAND ATTACHES TO THE NEEDLE. ANOTHER BOX OF SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181076 ↗
• MalfunctionDec 5, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE SKIN DURING AN OPEN ELECTROPHYSIOLOGY, THE NEEDLE DETACHED FROM THE STRAND WITH NORMAL USE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417116 ↗
• MalfunctionFeb 21, 2019Break; Break

  ACCORDING TO THE REPORTER, ON THE FINAL SKIN CLOSURE DURING A LAPAROSCOPIC VIDEO ASSISTED THORACOSCOPIC SURGERY, THE SUTURE BROKE AF TER ONE PASS THROUGH THE TISSUE. THEY WERE ABLE TO USE THE REST WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8360060 ↗
• MalfunctionMay 17, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACOSCOPIC RESECTION PROCEDURE, THE SURGEONS USED KNOT TECHNIQUE, AND WITHIN 30 SECONDS, THE THREAD BROKE AFTER 3 TIE ATTEMPTS. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522289 ↗

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