Polysorb CL-955Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521043718), received between Aug 17, 2018 and Apr 16, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Jun 15, 2018Terminated

   Potential proplylene glycol contamination

   Z-2601-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionApr 16, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING THE CESAREAN SECTION, WHILE SUTURING, NEEDLE DETACHMENT OCCURRED ON THREE CASES. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER TYPE OF SUTURE WAS USED AND THE ORIGINAL SUTURES WERE AVOIDED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895593 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO SUTURES BROKE WHILE SUTURING AT THE CONNECTION OF NEEDLE AND THREAD. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24615198 ↗
• MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL HIP ARTHROPLASTY USING MAKO, NEEDLE DETACHMENT OCCURRED WHILE CLOSING THE FASCIA. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069405 ↗
• InjuryOct 14, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CAESARIAN SECTION PROCEDURE, THE DEVICE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY. TO RESOLVE THE ISSUE THE SURGEON HAD TO REOPEN THE PATIENT AND FIND THE NEEDLE + CLOSE AGAIN. THE OPERATION TIME WAS EXTENDED FOR MORE THAN 30 MINUTES DUE TO THE DEVICE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12637224 ↗
• MalfunctionAug 17, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING FASCIA ON A CAESARIAN SECTION, THE NEEDLE BROKE. THEY OPENED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794447 ↗

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-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