Ti-Cron 88863093-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521060029), received between Aug 23, 2017 and Oct 6, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2023Material Frayed; Device Slipped; Material Frayed; Device Slipped

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED HIATAL HERNIA REPAIR WITH TOUPET FUNDOPLICATION AND GASTROPEXY, THERE WAS AN ISSUE WITH THE SUTURING OF THE FUNDOPLICATION. THE KNOTS TIED WERE NOT HOLDING WELL AND WERE FRAYING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17891142 ↗
• MalfunctionDec 20, 2019Break; Break

  ACCORDING TO THE REPORTER, AT THE LIGAMENT DURING AN OPEN ACHILLES TENDON REPAIR, THE THREAD BROKE. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9503971 ↗
• MalfunctionAug 11, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING INGUINAL HERNIA REPAIR, THE SUTURE BROKEN AT THE TIME OF MAKING THE KNOT DURING MESH FIXATION. THE SUTURE WAS COMPLETELY REMOVED AND THE FIXATION WAS MADE WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881951 ↗
• MalfunctionFeb 3, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING UMBILICAL HERNIA PROCEDURE, THE THREAD BROKE. ON THE END, WHEN THE SUTURE WAS KNOCKED IT WAS BROKEN. ANOTHER SUTURE WAS USE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8300620 ↗
• MalfunctionJan 11, 2019Break; Break

  ACCORDING TO THE REPORTER TOWARDS THE END OF A UMBILICAL HERNIA REPAIR PROCEDURE, WHILE SUTURING, THE THREAD OF THE DEVICE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR 20 MINUTES. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8240280 ↗
• MalfunctionAug 23, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN HERNIA PROCEDURE. THE SUTURE BROKE AT THE KNOT. NO KNOWN PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813480 ↗

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-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-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-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
• 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