Ti-Cron 88863147-89Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521060357), received between Jun 3, 2021 and May 31, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K930591); 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.

• MalfunctionMay 31, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING OPEN ABDOMINAL SURGERY, WHILE LIGATING, BEFORE USE, PACKAGING SHOULD HAVE FIVE SUTURES BUT THERE WERE ONLY FOUR SEEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550059 ↗
• MalfunctionJun 3, 2021Break; Break

  ACCORDING TO THE REPORTER, 44 DAYS AFTER TOTAL KNEE ARTHROPLASTY, THE PATIENT FELT DEFECT ON SUPEROMEDIAL BORDER PATELLA, ASPIRATE SYNOVASURE WAS DONE AND THE RESULT CAME OUT NEGATIVE FOR INFECTION. 57 DAYS AFTER THE ORIGINAL PROCEDURE, THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL, THE SURGERY SITE WAS CHECKED AND NO SUTURE WAS SEEN. THE ORIGINAL ABSORBABLE SUTURE THAT WAS USED TO HOLD THE TENDON MAY HAD BROKEN BETWEEN 2-3 WEEKS POST-OPERATIVELY AS PT REGIMEN BEGUN TO INCREASE. A NON-ABSORBABLE SUTURE WAS USED TO RESOLVE THE ISSUE, BUT THE SUTURE BROKE DURING HAND TYING. A PRODUCT FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935613 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K930591. One submission often covers many models, so check the product and lot details in each record.

• Z-2825-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material 8886300162 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, inclu
• Z-2829-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 2 BLUE 5X18" HGS-22 non-absorbable polyester sutures Material 8886337282 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, includi
• Z-2830-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, non-absorbable polyester sutures Material 8886337962 Ti-Cron is intended for use in general soft tissue approximation and/or lig
• Z-2826-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH non-absorbable polyester sutures Material 8886325962 Ti-Cron is intended for use in general soft tissue approximation and/or ligat
• Z-2827-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886326062 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, i
• Z-2828-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, i