Polysorb SL-690Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521049192), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, ON (B)(6) 2018, UNDER LOCAL ANESTHESIA, THE PATIENT UNDERWENT DEBRIDEMENT AND SUTURE OF SOFT TISSUE CONTUSION AND LACERATION ON THE BACK OF THE RIGHT FOOT AND LONG AND SHORT EXTENSOR TENDON RUPTURE AND ANASTOMOSIS OF GREAT TOE, WITH ABSORBABLE SURGICAL SUTURE TO SUTURE TENDON AND NON ABSORBABLE POLYESTER SUTURE TO SUTURE THE SKIN. ON (B)(6) 2018, THE PATIENT'S WOUND WAS REMOVED AND DISCHARGED. AFTER DISCHARGE, IT WAS FOUND THAT THE TENDON SUTURE WAS GRADUALLY DISCHARGED FROM THE BODY, WHICH AFFECTED THE LIFE OF THE PATIENT. THE PATIENT CAME TO THE HOSPITAL FOR FURTHER CONSULTATION ON (B)(6) 2019. THE SUTURE OF TENDON WAS REMOVED. THERE WAS REJECTION DUE TO THE PATIENT'S PHYSICAL CONDITION. NO OTHER DEVICES WERE USED IN COMBINATION. THERE WAS PATIENT INJURY.

  Patient problems: Foreign Body Reaction; Injury; No Code Available

  MAUDE report 9463630 ↗

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