Polysorb SL-823Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521049369), received between Sep 7, 2018 and Oct 16, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A REPLACEMENT OF BREAST IMPLANT, THE TIP OF THE NEEDLE BROKE OFF WHILE DURING A PASS OF SUTURE. SURGEON LOCATED THE FRAGMENT AND WAS ABLE TO RETRIEVE IT. SURGEON USED ANOTHER NEEDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196706 ↗
• MalfunctionSep 7, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE THE SURGEON USED AN INTERRUPTED AND SIMPLE CONTINUOUS SUTURING TECHNIQUE FOLLOWING A SPAY PROCEDURE OF PEDICLE LIGATION, SUB CUTANEOUS AND SUBCUTICULAR CLOSURE, THE PATIENT EXPERIENCED SUTURE REACTION. THEY TREATED THE PATIENT WITH ANTI-INFLAMMATORY AND ANTIBIOTIC TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7855404 ↗

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