Polysorb SL-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521048911), received between Dec 13, 2019 and Jun 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE PACKET WAS OPENED FOR ONE SUTURE IT WAS FOUND THAT THE TIP OF THE NEEDLE WAS BROKEN ALREADY, SO IT WAS NOT USED. ANOTHER SUTURE WAS THEN USED, AT THIS TIME, NEEDLE BREAKAGE OCCURRED WHILE GRASPING WITH A NEEDLE HOLDER. THE BROKEN NEEDLE DOES NOT APPEAR TO HAVE FALLEN INTO THE BODY CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238209 ↗
• MalfunctionOct 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE DEVICE WAS OPENED, THE NEEDLE WAS NOT ATTACHED. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725599 ↗
• MalfunctionDec 13, 2019Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO ORTHOPEDIC SURGERY, UPON OPENING THE PACKAGE, THERE WAS NO NEEDLE, ONLY THE THREAD. THE PRODUCT WAS NOT USED. A NEW DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 9465705 ↗

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