Polysorb SL-5627-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521048515), received between Oct 22, 2020 and Oct 26, 2020 — classified as 1 injury, 1 malfunction.

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 26, 2020Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE OFF TWICE WHILE SUTURING A PATIENT.

  Patient problems: No Information

  MAUDE report 10732819 ↗
• InjuryOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE NEEDLE DETACHED FROM THE THREAD AND LEFT IN THE SUBCUTANEOUS TISSUE. THE NEEDLE WAS NOT ABLE TO BE VISUALIZED DUE TO THE PATIENT'S BODY HABITUS. AFTER SOME MANEUVER THE NEEDLE EMERGE FROM THE SKIN BUT THE SURGEON FAILED TO GET IT. TO RESOLVE THE ISSUE THE SURGEON USED INSTRUMENTS AND SUPERFICIAL DISSECTION TOOL AND MADE NEW INCISION. A C-ARM ALSO WAS USED TO BE ABLE TO LOCATE THE NEEDLE WHICH WAS THEN SUCCESSFULLY RETRIEVED. THERE WERE TISSUE DAMAGE AS A RESULT OF THE DEVICE MALFUNCTION.

  Patient problems: No Code Available; Tissue Damage; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 10719019 ↗

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