Polysorb SL-1653Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521047488), received between Sep 20, 2021 and Mar 15, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjuryMar 15, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A POSTERIOR SPINAL FUSION, APPROXIMATELY TWO THIRDS OF THE NEEDLE BROKE OFF IN THE DERMIS WALL WHILE CLOSING SUBCUTICULAR LAYER. INCISION RE-OPENED FOR EXPLORATION. SURGEON WAS UNABLE TO LOCATE NEEDLE FRAGMENT EVEN IF IT WAS VISIBLE ON X-RAY. FRAGMENT RETAINED IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 13770652 ↗
• InjuryFeb 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE CLOSING OF THE DERMIS, THE NEEDLE BROKE. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE DUE TO THE NEED TO HAVE AN XRAY TO FIND PIECE OF RETAINED NEEDLE IN THE DERMIS. NEEDLE WAS SEEN ON XRAY, BUT UNABLE TO BE FOUND ONCE THE SURGEON REOPENED THE INCISION. INCISION WAS CLOSED WITH RETAINED PIECE OF NEEDLE STILL IN PATIENT. NEEDLE TIP WAS LEFT IN PATIENT TO BE "WORKED OUT ON ITS OWN" ACCORDING TO SURGEON.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 13625808 ↗
• MalfunctionSep 20, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLOSING THE TROCAR SITES, WITHIN ONE MINUTE USED, THE NEEDLE BROKE. TO COMPLETE THE CASE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501675 ↗

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