Polysorb SL-5638Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521048638), received between Jul 13, 2021 and Jan 3, 2023 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, THE THREAD BROKE AND THE NEEDLE DETACHED AS PER THE IMAGE. TO RESOLVE THE ISSUE, A COMPETITOR'S DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091480 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN OSTEOTOMY OF THE 1ST AND 5TH METATARSAL WHERE THE DEVICES WERE USED FOR CLOSING USING THE INTERRUPTED SUTURING TECHNIQUE, THE INCISION LINES WERE EXTREMELY INFLAMED. THE TISSUE WAS DAMAGED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 13261352 ↗
• MalfunctionSep 8, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A BREAST LIFT PROCEDURE, DURING THE CLOSURE OF THE NIPPLE TISSUE, THE DEVICE KEPT BREAKING. ANOTHER DEVICE FROM ANOTHER BOX WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441992 ↗
• MalfunctionJul 13, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A BREAST LIFT PROCEDURE, DURING THE CLOSURE OF THE NIPPLE TISSUE, THE DEVICE KEPT BREAKING. ANOTHER DEVICE FROM ANOTHER BOX WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164300 ↗

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