Polysorb CL-916Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521043343), received between Jan 30, 2018 and Apr 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THE TWO POLYSORB* 2-0 VIO 90CM GS11 X36 NEEDLES BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778474 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THE TWO NEEDLES BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775112 ↗
• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE REMOVING THE DEVICE FROM THE RETAINER, THE NEEDLE DETACHED PRIOR TO PATIENT INCISION. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631390 ↗
• MalfunctionDec 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE PERITONEUM DURING A CAESARIAN SECTION TO SEW THE FIRST STITCH, THE TWO SUTURES SEPARATED FROM THE NEEDLE. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984487 ↗
• MalfunctionSep 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE AN OPEN SKIN CLOSURE, THE SUTURE DID NOT ABSORB AS USUAL. THE DEVICE WAS REMOVED BY THE SURGEONS TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531686 ↗
• MalfunctionJan 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VAGINAL HYSTERECTOMY LAPAROSCOPIC PROCEDURE, THE NEEDLE CAME UNSET FROM THE THREAD. THE NEEDLE DID NOT FALL BUT STAYED IN THE NEEDLE DRIVER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228777 ↗

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